CHISEL (OSTEOTOME, GOUGE, ETC.)— 510(k) K864775

Name: FDA 510(k) clearance K864775
Creator: U.S. Food and Drug Administration
Published: 1987-02-12

Substantially Equivalent

New England Surgical Instrument Corp.

FDA 510(k) clearance K864775 for CHISEL (OSTEOTOME, GOUGE, ETC.), Substantially Equivalent on 1987-02-12. Applicant: New England Surgical Instrument Corp.. Device class: 1.

Clearance details

Applicant: New England Surgical Instrument Corp.
Product code: Code EMM
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1986-12-05
Decision date: 1987-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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