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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853242
Device Name I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI
Applicant
U.S. Mfg. & Management, Inc.
1802-F Commercenter W.
San Bernardino,  CA  92408
Applicant Contact FRANK J RAUSCHER
Correspondent
U.S. Mfg. & Management, Inc.
1802-F Commercenter W.
San Bernardino,  CA  92408
Correspondent Contact FRANK J RAUSCHER
Date Received08/01/1985
Decision Date 08/30/1985
Decision Substantially Equivalent - With Drug (SESD)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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