510(k) K770222
- Device
- IRIS RETRACTOR
- Applicant
- Concept, Inc.
- 510(k) number
- K770222
- Product code
- HNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-02-17
- Date received
- 1977-02-03
- Regulation
- 886.4350
- Classification name
- Retractor, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9611278
- 1057946
- 3010687973
- 3010041511
- 3004552850
- 9616250
- 9611112
- 2020550
- 3004475955
- 3013576617
- 9612075
- 9680718
- 1319639
- 3015451162
- 1720747
- 3036795921
- 3031231776
- 3029754081
- 1222993
- 1032347
- 1928237
- 3010202439
- 9680518
- 3008828237
- 3029990829
- 3010155661
- 1424263
- 3015177648
- 1421879
- 3004571672
- 3042228518
- 1646747
- 3011110913
- 3030451558
- 3007589150
- 9610905
- 3042940336
- 9710524
- 3013938829
- 3012185136
- 3017367014
- 3007334784
- 3021680161
- 3003418325
- 3003431869
- 3015895045
- 8043816
- 8010374
- 3007648354
- 3009773841
- 1313525
- 1934420
- 3003039352
- 3013096510
- 8044098
- 9680620
- 3008280196
- 9614107
- 3007583964
- 3008902714
- 2031962
- 3013602181
- 3010699884
- 3013503739
- 8021817
- 3005067367
- 3008754084
- 8010298
- 3005809810
- 1932180
- 2434839
- 9615857
- 8010694
- 1219518
- 2032098
- 9611283
- 9616245
- 3000264417
- 3007507973
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HNI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991592 | KSEA DE LA PLAZA BLEPHAROPLASTY SET | KARL STORZ Endoscopy-America, Inc. | 1999-11-02 |