SMOOTHSHAPES— 510(k) K061603

Substantially Equivalent

Biocellulase, Inc.

FDA 510(k) clearance K061603 for SMOOTHSHAPES, Substantially Equivalent on 2006-07-03. Applicant: Biocellulase, Inc.. Device class: 2.

Clearance details

Applicant
Biocellulase, Inc.
Product code
Code NUV
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Natick, MA, US
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