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
K833387Substantially Equivalent

Argon Laser Surgical System 770

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

K833387 is the FDA 510(k) clearance record for ARGON LASER SURGICAL SYSTEM 770, cleared for Cooper Medical Corp. on . FDA records list 5 510(k) clearances for Cooper Medical Corp., from to . As of , FDA records show no recalls naming K833387.

Clearance record

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