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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name airway, esophageal (obturator)
510(k) Number K863172
Device Name RESPIRONICS PTL REVIVEEASY
Applicant
RESPIRONICS, INC.
530 SECO RD.
MONROEVILLE,  PA  15146
Applicant Contact EUGENE N SCARSBERRY
Correspondent
RESPIRONICS, INC.
530 SECO RD.
MONROEVILLE,  PA  15146
Correspondent Contact EUGENE N SCARSBERRY
Regulation Number868.5650
Classification Product Code
CAO  
Date Received08/18/1986
Decision Date 11/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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