510(k) K812694
- Device
- Whisk-r
- Applicant
- MEDI-SPEC
- 510(k) number
- K812694
- Product code
- GEE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-10-26
- Date received
- 1981-09-22
- Regulation
- 878.4800
- Classification name
- Brush, Biopsy, General & Plastic Surgery
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9680221
- 2529846
- 3014383302
- 1450908
- 3014610488
- 1721686
- 3008808042
- 9680254
- 1057425
- 3008338766
- 1836161
- 3011371465
- 1412854
- 2249529
- 1223925
- 3017178443
- 3004215117
- 1320894
- 2246552
- 3007517215
- 3010726901
- 2023790
- 3015745029
- 3003717263
- 1056129
- 3019387954
- 1220592
- 3007305485
- 3007597038
- 1720747
- 3024860669
- 1061927
- 3005941719
- 3008004502
- 3009337401
- 3003807268
- 3012314549
- 1820334
- 2032098
- 3003965134
- 8040278
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K854003 | STERILE SOFT TISSUE BIOPSY NEEDLE | Co-Medical, Inc. | 1985-10-18 |
| K841008 | BIOPSY PUNCH, VARIOUS | Premier Dental Products Co. | 1984-06-08 |
| K822490 | DEFLECTING CYTOLOGY BRUSH | Van-Tec, Inc. | 1982-09-14 |
| K820259 | STERILE CYTOLOGY BRUSHES | American Endoscopy, Inc. | 1982-03-05 |
| K801304 | CAMLOC SYRINGE BIOPSY KIT | Johannah Medical Services, Inc. | 1980-06-17 |
| K792316 | TROTEX II SCREW NEEDLE BIOPSY INSTR. SET | Ursus Konsult AB | 1979-12-18 |