STERILE AMBULATORY RESERVOIR 60ML/100ML— 510(k) K962159
Substantially EquivalentFaulding Medical Device Co.
FDA 510(k) clearance K962159 for STERILE AMBULATORY RESERVOIR 60ML/100ML, Substantially Equivalent on 1997-07-18. Applicant: Faulding Medical Device Co.. Device class: 2.
Clearance details
- Applicant
- Faulding Medical Device Co.
- Product code
- Code MRZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
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