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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Pneumatic
510(k) Number K935356
Device Name CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES
Applicant
Amsco American Sterilizer Co.
2424 W. 23rd St.
P.O. Box 620
Erie,  PA  16514
Applicant Contact LORI A HALLER
Correspondent
Amsco American Sterilizer Co.
2424 W. 23rd St.
P.O. Box 620
Erie,  PA  16514
Correspondent Contact LORI A HALLER
Regulation Number878.4960
Classification Product Code
FWW  
Date Received11/04/1993
Decision Date 03/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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