510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830867Substantially Equivalent

Reflex One Staple Extractor

Richard-Allan Medical Ind., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830867 is the FDA 510(k) clearance record for REFLEX ONE STAPLE EXTRACTOR, cleared for Richard-Allan Medical Ind., Inc. on . FDA records list 33 510(k) clearances for Richard-Allan Medical Ind., Inc., from to . As of , FDA records show no recalls naming K830867.

Clearance record

Decision date
Received
(25 days to decision)
Review panel
Unknown
Applicant
Richard-Allan Medical Ind., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No