510(k) K853242

I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI by U.S. Mfg. & Management, Inc.

K853242 is an FDA 510(k) premarket notification submitted by U.S. Mfg. & Management, Inc. for the device "I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI". The FDA issued a decision of Substantially Equivalent (with conditions) on August 30, 1985. U.S. Mfg. & Management, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
August 30, 1985
Date Received
August 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No