510(k) K851711

600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE by Artiberia — Product Code EMG

K851711 is an FDA 510(k) premarket notification submitted by Artiberia for the device "600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE". The FDA issued a decision of Substantially Equivalent on Jun 11, 1985. The device falls under product code EMG (Forceps, Tooth Extractor, Surgical), a Class I device regulated under 21 CFR 872.4565. Artiberia has 78 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 11, 1985
Date Received
Apr 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Forceps, Tooth Extractor, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K851711. Report a data issue: hello@regdatalab.com.