510(k) K822109
- Device
- Shovel Retractor
- Applicant
- BIO-BLITZ, INC.
- 510(k) number
- K822109
- Product code
- NBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-30
- Date received
- 1982-07-19
- Regulation
- 888.1100
- Classification name
- Accessories, Arthroscopic
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- 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#
- 1221934
- 3013700547
- 3021477808
- 1045254
- 3008513917
- 3011070496
- 9616086
- 3010331645
- 3015806723
- 3021907852
- 2031093
- 1836357
- 8043817
- 1828464
- 1526534
- 8044057
- 1000517406
- 3014023545
- 8044098
- 9710457
- 3015399803
- 3027242374
- 2320767
- 3043236407
- 1721676
- 3015167917
- 1424263
- 3011401113
- 3010039400
- 3015974593
- 8010257
- 3006128100
- 3003477135
- 3017450165
- 3005641619
- 2020550
- 3009973336
- 2936485
- 3003973936
- 3010707607
- 3016678045
- 1833986
- 3016443334
- 8043746
- 3010202439
- 1647149
- 3012358417
- 3017607477
- 3010011359
- 1220246
- 3021970868
- 3033509898
- 3006524618
- 3021336182
- 3020899789
- 1822565
- 3007305485
- 3004361445
- 3003120897
- 9611112
- 3015259876
- 1222928
- 1825034
- 3008114965
- 3006467300
- 3030514683
- 9610617
- 2011171
- 1036836
- 3014262693
- 3015895045
- 3016851379
- 8010349
- 3014342658
- 9611610
- 3009732568
- 3009141957
- 3009513193
- 1054811
- 3030535035
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NBH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K822560 | IRRIGATION SET | Utah Medical Products, Inc. | 1982-12-03 |