SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC
FDA 510(k) clearance K900439 · decided 1990-02-15
Clearance details
- K-number
- K900439
- Device name
- SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC
- Applicant
- L H M Ent., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-29
- Decision date
- 1990-02-15
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- FIH
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Indian Mills, NJ, 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 |
|---|---|---|
| PERCUPUMP II (K932055) | E-Z-Em, Inc. | 1995-03-21 |
| VECTOR AMBULATORY DRUG DELIVERY SYSTEM (K935461) | Infusion Technology Intl. | 1994-04-28 |
| CADD-TPN(TM) AMBULATORY INFUSION SYSTEM (K931113) | Pharmacia Deltec, Inc. | 1994-04-28 |
| INTROCULAR FLUID INJECTOR (K881707) | B&B Medical Assoc., Inc. | 1988-10-21 |
Recalls involving this device
No recalls on record reference this clearance.