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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tent, Oxygen
510(k) Number K852345
Device Name SEA-LONG NECKSEAL & HOOD
Applicant
Safety Sea Systems, Inc.
207 Kah-Lac Ln. Rt.2
Ponchatoula,  LA  70454
Applicant Contact GEORGE WYMER
Correspondent
Safety Sea Systems, Inc.
207 Kah-Lac Ln. Rt.2
Ponchatoula,  LA  70454
Correspondent Contact GEORGE WYMER
Regulation Number868.5700
Classification Product Code
BYL  
Date Received05/31/1985
Decision Date 06/20/1985
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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