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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name applicator, ent drug
510(k) Number K932522
Device Name AMSCO STERILE RECOVERIES SURGICAL PACKS
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 Number874.5220
Classification Product Code
LRD  
Date Received05/25/1993
Decision Date 09/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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