SUPERLON (UNILON) CARBOXYLATE CEMENT— 510(k) K861685

Name: FDA 510(k) clearance K861685
Creator: U.S. Food and Drug Administration
Published: 1986-05-19

Substantially Equivalent

Carlisle Laboratories, Inc.

FDA 510(k) clearance K861685 for SUPERLON (UNILON) CARBOXYLATE CEMENT, Substantially Equivalent on 1986-05-19. Applicant: Carlisle Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Carlisle Laboratories, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1986-05-02
Decision date: 1986-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Inwood, NY, US

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