ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI— 510(k) K132198

Substantially Equivalent

Ceremed , Inc.

FDA 510(k) clearance K132198 for ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI, Substantially Equivalent on 2013-09-12. Applicant: Ceremed , Inc.. Device class: 2.

Clearance details

Applicant
Ceremed , Inc.
Product code
Code KHJ
Device class
Class 2
Regulation
21 CFR 874.3620
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Los Angeles, CA, US
Download summary PDFView on FDA.gov ↗

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