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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, obstetric (and accessories)
510(k) Number K932035
Device Name NON-LINTING DELIVERY BLANKET
Applicant
AMSCO STERILE RECOVERIES, INC.
28100 U.S. HWY, 19N., STE. 201
CLEARWATER,  FL  34621
Applicant Contact DENISE A SCHOTTLER
Correspondent
AMSCO STERILE RECOVERIES, INC.
28100 U.S. HWY, 19N., STE. 201
CLEARWATER,  FL  34621
Correspondent Contact DENISE A SCHOTTLER
Regulation Number884.4900
Classification Product Code
KNC  
Date Received04/27/1993
Decision Date 05/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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