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#
- 3003935342
- 3043620689
- 9611278
- 3015974593
- 9611112
- 3004957622
- 2020550
- 3038191237
- 3004464325
- 1721676
- 9615004
- 3015399803
- 3011989923
- 1036836
- 1020279
- 3005061536
- 3009499159
- 1221934
- 3026133770
- 9680718
- 1835572
- 3013404959
- 1835251
- 3009141957
- 3014004349
- 3010202439
- 9617426
- 3023852420
- 2031917
- 3006467300
- 1835998
- 3010692967
- 1424263
- 9710629
- 3016678045
- 1421879
- 3005180920
- 3012329552
- 2032677
- 3010546717
- 2134285
- 3003973936
- 2320767
- 9610617
- 3014615697
- 3007305485
- 9615896
- 3012818475
- 3011373951
- 3014315669
- 8010273
- 3010659131
- 3012267976
- 3030514683
- 1412854
- 1223421
- 2011171
- 3014680784
- 3016727307
- 3018094310
- 3024021261
- 1064017
- 3015895045
- 3013700547
- 1422634
- 3010400367
- 3042508254
- 1528668
- 3006561161
- 1643817
- 3011299238
- 9611665
- 3009144915
- 1017294
- 1058584
- 8010697
- 8044098
- 3015259876
- 2245304
- 3009973336
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 |