510(k) K802850
- Device
- TECNOL O.R. TOURNIQUET COVER
- Applicant
- TECNOL NEW JERSEY WOUND CARE, INC.
- 510(k) number
- K802850
- Product code
- EYR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-01-13
- Date received
- 1980-11-12
- Regulation
- 878.5900
- Classification name
- Tourniquet, Gastro-urology
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 368 Fairview Ave. Hammonton NJ US 08037 08037
FDA Registration Numbers#
- 8030607
- 3004608878
- 3005273623
- 1417592
- 3005809810
- 3011137372
- 9611274
- 3013530901
- 1421101
- 3010041511
- 3003418325
- 8040278
- 3004365956
- 1836161
- 3014334038
- 3007518347
- 1056350
- 3001644167
- 3005528784
- 3008770252
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EYR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K792256 | KEITHLEY CLAMP | Keithley Development Co. | 1979-12-06 |
Legacy Summary#
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FDA Review#
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