BLAKEMORE RETAINER— 510(k) K880253

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K880253 for BLAKEMORE RETAINER, Substantially Equivalent on 1988-03-11. Applicant: Orthopedic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code FEF
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1988-01-20
Decision date: 1988-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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