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
K801606Substantially Equivalent

Retreat

Omnitronics Research Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801606 is the FDA 510(k) clearance record for RETREAT, cleared for Omnitronics Research Corp. on . FDA records list one 510(k) clearance for Omnitronics Research Corp. As of , FDA records show no recalls naming K801606.

Clearance record

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