510(k) K853242
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