510(k) K811887
- Device
- Skin Staple Extractor
- Applicant
- SIERRA LABORATORIES, INC.
- 510(k) number
- K811887
- Product code
- KBC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-27
- Date received
- 1981-07-01
- Regulation
- 874.4420
- Classification name
- Saw, Nasal
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- 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#
- 8043816
- 3003696170
- 1926681
- 3014615697
- 3003244954
- 3013247477
- 3008936260
- 3003418325
- 3011371465
- 1836161
- 9613926
- 1923569
- 9610612
- 1057946
- 3006554912
- 1421879
- 3013497507
- 3014334038
- 3003431869
- 3022862651
- 3029082594
- 2916714
- 9611112
- 3010726901
- 3007773213
- 9610773
- 2431166
- 9611283
- 3007137643
- 3005809810
- 9613083
- 3016825318
- 1720747
- 3012226300
- 3036795921
- 2434839
- 8010433
- 9680518
- 9610905
- 8044098
- 3011050570
- 3008770252
- 8030607
- 9680718
- 3015895045
- 3009513193
- 8010099
- 9611278
- 3006142527
- 3011137372
- 3022320321
- 3004608878
- 9680519
- 3024988980
- 3010041511
- 3001620590
- 9615857
- 8040278
- 3008808049
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KBC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K810187 | AUTO SUTURE PSS SKIN STAPLING INSTRUMENT | United States Surgical, A Division of Tyco Healthc | 1981-03-20 |
| K810188 | AUTO SUTURE GAS POWERED DISP. LDS STAPL | United States Surgical, A Division of Tyco Healthc | 1981-03-20 |
| K772379 | JOSEPH SAW | Edward Weck, Inc. | 1978-02-02 |