510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834339Substantially Equivalent

Boundary Reinforced Single-Use Gowns

Procter & Gamble Mfg. Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834339 is the FDA 510(k) clearance record for BOUNDARY REINFORCED SINGLE-USE GOWNS, cleared for Procter & Gamble Mfg. Co. on . FDA records list 72 510(k) clearances for Procter & Gamble Mfg. Co., from to . As of , FDA records show no recalls naming K834339.

Clearance record

Decision date
Received
(84 days to decision)
Review panel
Unknown
Applicant
Procter & Gamble Mfg. Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No