REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST— 510(k) K080418

Name: FDA 510(k) clearance K080418
Creator: U.S. Food and Drug Administration
Published: 2008-04-30

Substantially Equivalent

Regeneration Technologies, Inc.

FDA 510(k) clearance K080418 for REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST, Substantially Equivalent on 2008-04-30. Applicant: Regeneration Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Regeneration Technologies, Inc.
Product code: Code NUN
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2008-02-15
Decision date: 2008-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, US

Download summary PDF View on FDA.gov ↗

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