510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821334Substantially Equivalent

Omed Fabric Instrument Covers-Radiopaq

Omega-Med Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821334 is the FDA 510(k) clearance record for OMED FABRIC INSTRUMENT COVERS-RADIOPAQ, cleared for Omega-Med Intl., Inc. on . FDA records list 9 510(k) clearances for Omega-Med Intl., Inc., from to . As of , FDA records show no recalls naming K821334.

Clearance record

Decision date
Received
(19 days to decision)
Review panel
Unknown
Applicant
Omega-Med Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No