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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K862335
Device Name MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT
Applicant
U.S. Mfg. & Management, Inc.
287 S. Stoddard Ave.
San Bernardino,  CA  92401
Applicant Contact FRANK J RAUSCHER
Correspondent
U.S. Mfg. & Management, Inc.
287 S. Stoddard Ave.
San Bernardino,  CA  92401
Correspondent Contact FRANK J RAUSCHER
Date Received06/19/1986
Decision Date 07/24/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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