510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862335Substantially Equivalent for Some Indications

Modified i.v. Start, Re-Start, Pedi and Geri-Kit

U.S. Mfg. & Management, Inc., San Bernardino CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K862335 is the FDA 510(k) clearance record for MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT, cleared for U.S. Mfg. & Management, Inc. on . FDA records list 5 510(k) clearances for U.S. Mfg. & Management, Inc., from to . As of , FDA records show no recalls naming K862335.

Clearance record

Decision date
Received
(35 days to decision)
Review panel
Unknown
Applicant
U.S. Mfg. & Management, Inc. 287 S. Stoddard Ave., San Bernardino CA
Third party review
No