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
K830737Substantially Equivalent

Jermyn Occluders Kit

Jermyn Specialties of California, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830737 is the FDA 510(k) clearance record for JERMYN OCCLUDERS KIT, cleared for Jermyn Specialties of California on . FDA records list 2 510(k) clearances for Jermyn Specialties of California, from to . As of , FDA records show no recalls naming K830737.

Clearance record

Decision date
Received
(86 days to decision)
Review panel
Unknown
Applicant
Jermyn Specialties of California 4221 Richmond Rd., NW, Walker MI
Third party review
No