AUTOMATIC TEFLON INJECTION SYRINGE
FDA 510(k) clearance K810284 · decided 1981-03-11
Clearance details
- K-number
- K810284
- Device name
- AUTOMATIC TEFLON INJECTION SYRINGE
- Applicant
- R. Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-02
- Decision date
- 1981-03-11
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- KCP
- Device class
- 1
- Regulation number
- 874.5220
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- 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 |
|---|---|---|
| CAT. 7-EAR, NOSE & THROAT DEVICES (K840311) | Imm Enterprises , Ltd. | 1984-05-09 |
| EAR/ULCER SYRINGE (K822754) | American Hospital Supply Corp. | 1982-10-04 |
| SYRINGE, EAR & ULCER (K780599) | Abco Dealers, Inc. | 1978-04-19 |
Recalls involving this device
No recalls on record reference this clearance.