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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K910621
Device Name BLADES FOR SPINAL LAMINECTOMY RETRACTOR
Applicant
International Hospital Supply Co.
18321 Ventura Blvd. #1010
Tarzana,  CA  91356
Applicant Contact GEORGE O SHECTER
Correspondent
International Hospital Supply Co.
18321 Ventura Blvd. #1010
Tarzana,  CA  91356
Correspondent Contact GEORGE O SHECTER
Regulation Number882.4800
Classification Product Code
GZT  
Date Received02/12/1991
Decision Date 04/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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