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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K955661
Device Name ACU-HALT
Applicant
Glederer & Co., Inc.
503 E. 40th St.
Paterson,  NJ  07504
Applicant Contact GABE LEDERER
Correspondent
Glederer & Co., Inc.
503 E. 40th St.
Paterson,  NJ  07504
Correspondent Contact GABE LEDERER
Classification Product Code
LDQ
Date Received12/12/1995
Decision Date 12/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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