DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND— 510(k) DEN980001

Name: FDA 510(k) clearance DEN980001
Creator: U.S. Food and Drug Administration
Published: 1998-05-29

Unknown

Cranial Technologies, Inc.

FDA 510(k) clearance DEN980001 for DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND, Unknown on 1998-05-29. Applicant: Cranial Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Cranial Technologies, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 1998-03-31
Decision date: 1998-05-29
Decision: Unknown
Clearance type: Post-NSE
Location: Phoenix, AZ, US

View on FDA.gov ↗

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