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			Model 004 - Visual
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			Model 007 - Visual

SLUMBERGEAR™ MODEL 004

MODEL 004 The Best CPAP Headgear Available on the Market Today!

• SLUMBERGEAR® headgear is a revolutionary new accessory that offers safe, uninterrupted sleep to CPAP patients.

• The seamless one-piece design of SLUMBERGEAR® integrates all parts into the headgear including achin portion.

• The chin portion anchors SLUMBERGEAR® to help provide a perfectly balanced 4 point headgear and mask securement system with the added bonus of chin support.

• 4 Different Models intended to secure most "on the face” respiratory devices. Ask your Physician, your Sleep Therapist or your Home Medical Provider for more information about the full product line of SLUMBERGEAR®.

VISUAL COMPARISON - MODEL 004

Substantially Equivalent Comparison of Predicate Device to New SLUMBERGEAR® Device

Devices Currently On the Market

New Device - SLUMBERGEAR®-004

Predicate headgear (shown securing regular nasal mask with forehead assembly) A separate chinstrap is secured. REMstar Pro with C-Flex (K021861) This style headgear is supplied with REMstar Pro.

SLUMBERGEAR® 004 - intended to secure nasal masks and full face masks with forehead assembly