PHARMACY ADDITIVE SYRINGE SET
FDA 510(k) clearance K800213 · decided 1980-02-26
Clearance details
- K-number
- K800213
- Device name
- PHARMACY ADDITIVE SYRINGE SET
- Applicant
- Cutter Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-01
- Decision date
- 1980-02-26
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- KYW
- Device class
- 1
- Regulation number
- 880.6430
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDICINE CUP (K791345) | General Clinical Plastics Corp. | 1979-08-03 |
Recalls involving this device
No recalls on record reference this clearance.