MODIFICATION TO VF GEL PLUS— 510(k) K080956

Substantially Equivalent

Coapt Systems, Inc.

FDA 510(k) clearance K080956 for MODIFICATION TO VF GEL PLUS, Substantially Equivalent on 2008-04-25. Applicant: Coapt Systems, Inc.. Device class: 2.

Clearance details

Applicant
Coapt Systems, Inc.
Product code
Code MIX
Device class
Class 2
Regulation
21 CFR 874.3620
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Palo Alto, CA, US
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