DA-46 FLUID BARRIER— 510(k) K891752
Substantially EquivalentAkcess Medical Products, Inc.
FDA 510(k) clearance K891752 for DA-46 FLUID BARRIER, Substantially Equivalent on 1989-04-07. Applicant: Akcess Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Akcess Medical Products, Inc.
- Product code
- Code FIB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Brunswick, NJ, US
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