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#
- 3022862651
- 3004571672
- 3007648354
- 8010376
- 3013497507
- 3029990829
- 8040884
- 8040233
- 3013602181
- 8044098
- 3016965929
- 3003803182
- 2020550
- 1313525
- 3035678069
- 1720747
- 3003418325
- 9610612
- 9611283
- 3007507973
- 3008770252
- 1934420
- 9610905
- 3045853999
- 1056350
- 1720929
- 8010298
- 3008280196
- 8040381
- 9616250
- 1417592
- 3042940336
- 3005440795
- 3006550126
- 3000264417
- 3013938829
- 9613079
- 1032347
- 1646747
- 9616246
- 2242450
- 3010155661
- 9616245
- 8040278
- 8021817
- 1219518
- 9615857
- 2032098
- 1057946
- 3004552850
- 3007583964
- 3030451558
- 3008828237
- 3007334784
- 8043235
- 3020723591
- 3029754081
- 3005225959
- 3036795921
- 9680718
- 1211998
- 3033566
- 3002675176
- 3011137372
- 3019924
- 3008338766
- 3031231776
- 3005528784
- 8043368
- 1836161
- 3007589150
- 3014334038
- 2434839
- 9680518
- 3007317099
- 3012995405
- 1058726
- 1045379
- 3017367014
- 3015451162
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 |