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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K934703
Device Name MEDICOOL PROTECTALL
Applicant
Avc Regulatory Compliance/Technical Services
P.O. Box 30
Greeves Rd.
New Hampton,  NY  10958
Applicant Contact A V CALOGERO
Correspondent
Avc Regulatory Compliance/Technical Services
P.O. Box 30
Greeves Rd.
New Hampton,  NY  10958
Correspondent Contact A V CALOGERO
Classification Product Code
LDQ
Date Received09/30/1993
Decision Date 01/26/1994
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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