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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strap, Head, Gas Mask
510(k) Number K810991
Device Name HEADSTRAP
Applicant
Respironics, Inc.
530 Seco Rd.
Monroeville,  PA  15146
Correspondent
Respironics, Inc.
530 Seco Rd.
Monroeville,  PA  15146
Regulation Number868.5560
Classification Product Code
BTK  
Date Received04/13/1981
Decision Date 04/29/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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