BERACLAMP, MODEL BC-1— 510(k) K990045

Substantially Equivalent

Poamax LLC

FDA 510(k) clearance K990045 for BERACLAMP, MODEL BC-1, Substantially Equivalent on 1999-05-24. Applicant: Poamax LLC. Device class: 2.

Clearance details

Applicant: Poamax LLC
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1999-01-06
Decision date: 1999-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poguoson, VA, US

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