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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gauze/sponge, internal, x-ray detectable
510(k) Number K873391
Device Name MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
Applicant
ORMED MFG., INC.
175 GREAT ARROW AVE.
BUFFALO,  NY  14207
Applicant Contact ALEX BALAZ
Correspondent
ORMED MFG., INC.
175 GREAT ARROW AVE.
BUFFALO,  NY  14207
Correspondent Contact ALEX BALAZ
Regulation Number878.4450
Classification Product Code
GDY  
Date Received08/24/1987
Decision Date 09/11/1987
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
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