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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 K852304
Device Name SAFE-N-JECT
Applicant
Gerstner Intl. Trade
282 St. Albans Ave.
South Pasadena,  CA  91030
Applicant Contact DEENA B GERSTNER
Correspondent
Gerstner Intl. Trade
282 St. Albans Ave.
South Pasadena,  CA  91030
Correspondent Contact DEENA B GERSTNER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/29/1985
Decision Date 09/20/1985
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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