510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831635Substantially Equivalent

Acu-Punch

Acuderm, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831635 is the FDA 510(k) clearance record for ACU-PUNCH, cleared for Acuderm, Inc. on . FDA records list 13 510(k) clearances for Acuderm, Inc., from to . As of , FDA records show no recalls naming K831635.

Clearance record

Decision date
Received
(48 days to decision)
Review panel
Unknown
Applicant
Acuderm, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No