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#
- 9610612
- 3014032451
- 3012818475
- 3018094310
- 3004504812
- 3008868758
- 1822565
- 3002579136
- 3013011598
- 3015259876
- 3021008900
- 3039017337
- 3007319107
- 8010273
- 1835572
- 1226544
- 3008837339
- 3009702671
- 3012322232
- 8010298
- 1528668
- 3010047402
- 3005180920
- 3035678069
- 3009381600
- 3011373951
- 3030514683
- 3005575604
- 3007125392
- 3010707607
- 3015330458
- 3013302242
- 3006108336
- 1418479
- 3016727307
- 2134285
- 3006846753
- 3003139373
- 9611610
- 3008114965
- 3003477135
- 3009756153
- 3015806723
- 3043226252
- 3005641619
- 8043746
- 1222773
- 2953359
- 3015972835
- 3033509898
- 3008812560
- 3012329552
- 3004957622
- 8040278
- 9616086
- 2936485
- 3010128826
- 3008911114
- 3010400367
- 3021226419
- 2032830
- 3030682078
- 9611503
- 3001239363
- 3005677016
- 2522206
- 3009106092
- 3021336182
- 3043236407
- 2032092
- 3011230048
- 1833986
- 3011295718
- 3015183635
- 3024021261
- 3011989923
- 2085947
- 3009732568
- 3003500271
- 3014023545
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 |