510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K862804Substantially Equivalent

Spunguard Hospital Coverall

Kimberly-Clark Corporation, Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862804 is the FDA 510(k) clearance record for SPUNGUARD HOSPITAL COVERALL, cleared for Kimberly-Clark Corp. on . FDA records list 122 510(k) clearances for Kimberly-Clark Corp., from to . As of , FDA records show no recalls naming K862804.

Clearance record

Decision date
Received
(20 days to decision)
Review panel
Unknown
Applicant
Kimberly-Clark Corp. 1400 Holcomb Bridge Rd., Roswell GA
Third party review
No