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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K953626
Device Name SYRINGE MAGNIFIER
Applicant
Innovative Premiums, Inc.
3571 Hargale Rd.
Oceanside,  NY  11572
Applicant Contact JUDAH ISAACS
Correspondent
Innovative Premiums, Inc.
3571 Hargale Rd.
Oceanside,  NY  11572
Correspondent Contact JUDAH ISAACS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/02/1995
Decision Date 12/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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