510(k) K822108
- Device
- Cement-pick
- Applicant
- BIO-BLITZ, INC.
- 510(k) number
- K822108
- Product code
- GAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-11
- Date received
- 1982-07-19
- Regulation
- 878.4800
- Classification name
- Spatula, Surgical, 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#
- 3023657851
- 9611112
- 3005440795
- 8010372
- 3004215117
- 2431166
- 8043507
- 3006059835
- 1421879
- 1056350
- 3009703496
- 3004892425
- 3003038445
- 8040278
- 3002090132
- 8010099
- 3010041511
- 3035678069
- 1923569
- 3010687973
- 3009465247
- 3005225959
- 9611827
- 3008338766
- 1526350
- 8040263
- 9681540
- 9611283
- 3004193466
- 9613926
- 3007597038
- 3004598675
- 8040881
- 3010399422
- 9681161
- 3011585752
- 3010055973
- 3035858921
- 8040172
- 3001146947
- 8010159
- 8043816
- 3009340886
- 3015895045
- 3008808049
- 3002808270
- 3001297506
- 3027556548
- 3005663073
- 1032347
- 3001620590
- 3002761766
- 3005587147
- 3004168759
- 8010704
- 3008346537
- 3013946322
- 3026326493
- 3014937043
- 8041151
- 3015168527
- 3013358456
- 3004001706
- 9610773
- 1928237
- 1836161
- 3002858762
- 3004571672
- 3010726901
- 3014908171
- 9614075
- 3029082594
- 1319639
- 3031231776
- 3014346934
- 1419489
- 3003956316
- 3003644849
- 3010288346
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GAF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023688 | LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER | LeMaitre Vascular, Inc. | 2003-01-30 |
| K935357 | SNAP RECIPROCATING SAW | Surgiquip, Inc. | 1994-01-28 |
| K890374 | ABDOMINAL SPATULA | Kinetic Medical Products | 1989-02-03 |
| K882793 | PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE | Pmt Corp. | 1988-07-18 |