B. FRAGTEX— 510(k) K881380

Substantially Equivalent

American Biomedical Products, Inc.

FDA 510(k) clearance K881380 for B. FRAGTEX, Substantially Equivalent on 1988-10-06. Applicant: American Biomedical Products, Inc.. Device class: 1.

Clearance details

Applicant: American Biomedical Products, Inc.
Product code: Code JSP
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1988-04-01
Decision date: 1988-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.