45 DEGREE SHAVER— 510(k) K870882

Name: FDA 510(k) clearance K870882
Creator: U.S. Food and Drug Administration
Published: 1987-03-23

Substantially Equivalent

Bowen & Company, Inc.

FDA 510(k) clearance K870882 for 45 DEGREE SHAVER, Substantially Equivalent on 1987-03-23. Applicant: Bowen & Company, Inc.. Device class: 1.

Clearance details

Applicant: Bowen & Company, Inc.
Product code: Code HTZ
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-03-05
Decision date: 1987-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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K896898 — BOWEN ELECTRODE SKIN PREPATORY CLEANSER1990-04-04
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K873766 — STERNAL POWER AWL1988-11-14
K872098 — CREMEEN ALVEOLAR BONE CALIPER1987-07-31
K871325 — BOWEN REUSEABLE/DISPOSABLE ELECTRODE1987-06-08

Adverse events under product code HTZ

product code HTZ

Malfunction: 1,133
Total: 1,133

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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