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#
- 9614069
- 3022862651
- 3004571672
- 3007648354
- 8040884
- 3016894896
- 8040233
- 1526350
- 3003905396
- 8044098
- 3003334541
- 3016965929
- 3005587147
- 3005813597
- 9615005
- 3002719998
- 3035678069
- 1720747
- 3003418325
- 3012226300
- 9610612
- 9611283
- 3006059835
- 3013552516
- 3008770252
- 9610905
- 3045853999
- 1056350
- 2246990
- 1066741
- 8010298
- 3003956316
- 3001297506
- 8040263
- 9616250
- 3003597504
- 1417592
- 8040172
- 3005440795
- 3002769835
- 3002858762
- 9611274
- 3013247477
- 3004193466
- 9613079
- 1032347
- 1646747
- 9616246
- 3003032798
- 3001408183
- 3006891796
- 8040278
- 8010732
- 3014201171
- 1057946
- 3003038445
- 3004552850
- 3010399422
- 8043752
- 8040881
- 5906
- 3005621335
- 3005897698
- 9612278
- 3009703496
- 9680519
- 3005225959
- 8010890
- 3036795921
- 3004598675
- 9680718
- 3013846070
- 3009513193
- 3002834291
- 9613926
- 8043554
- 3002761766
- 3011137372
- 9612074
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 |