510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K801312Substantially Equivalent

The Protectors

Cooper Medical Devices Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801312 is the FDA 510(k) clearance record for THE PROTECTORS, cleared for Cooper Medical Devices Corp. on . FDA records list 7 510(k) clearances for Cooper Medical Devices Corp., from to . As of , FDA records show no recalls naming K801312.

Clearance record

Decision date
Received
(14 days to decision)
Review panel
Unknown
Applicant
Cooper Medical Devices Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No