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
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K781672Substantially Equivalent

Acu-Dot

Acu-Dot Pharmaceutical Intl., Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781672 is the FDA 510(k) clearance record for ACU-DOT, cleared for Acu-Dot Pharmaceutical Intl., Inc. on . FDA records list one 510(k) clearance for Acu-Dot Pharmaceutical Intl., Inc. As of , FDA records show no recalls naming K781672.

Clearance record

Decision date
Received
(36 days to decision)
Review panel
Unknown
Applicant
Acu-Dot Pharmaceutical Intl., Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No