COLONIC BALLOON DIALATORS— 510(k) K884713

Substantially Equivalent

Primrose Medical, Inc.

FDA 510(k) clearance K884713 for COLONIC BALLOON DIALATORS, Substantially Equivalent on 1989-09-29. Applicant: Primrose Medical, Inc..

Clearance details

Applicant: Primrose Medical, Inc.
Product code: Code FFP
Advisory panel: Gastroenterology, Urology
Date received: 1988-11-08
Decision date: 1989-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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