COLONIC BALLOON DIALATORS— 510(k) K884713
Substantially EquivalentPrimrose Medical, Inc.
FDA 510(k) clearance K884713 for COLONIC BALLOON DIALATORS, Substantially Equivalent on 1989-09-29. Applicant: Primrose Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Primrose Medical, Inc.
- Product code
- Code FFP
- Device class
- Class 1
- Regulation
- 21 CFR 876.5450
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woburn, MA, US
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