BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
FDA 510(k) clearance K081547 · decided 2008-09-08
Clearance details
- K-number
- K081547
- Device name
- BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
- Applicant
- Bio-Med USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-02
- Decision date
- 2008-09-08
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Paterson, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.