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#
- 1417592
- 9615857
- 3006677911
- 3015972897
- 9680620
- 3007334784
- 8010547
- 2431166
- 3033566
- 3010041511
- 2518410
- 1045379
- 3013576617
- 3030451558
- 9613079
- 3032747418
- 3004001706
- 3011371465
- 3009465247
- 3012995405
- 1222993
- 1836161
- 1450662
- 1056350
- 9616246
- 8010374
- 1058726
- 9616250
- 3033536312
- 9710524
- 2032098
- 3017367014
- 3008280196
- 3012185136
- 1935627
- 9612075
- 8010665
- 1313525
- 3035678069
- 2434839
- 3003951061
- 3010202439
- 3008902714
- 3016965929
- 9610612
- 3020723591
- 3013938829
- 1424263
- 1646747
- 3005528784
- 9616245
- 9611278
- 3005225959
- 3015451162
- 1929756
- 3011110913
- 3003039352
- 8040278
- 3011137372
- 3013503739
- 9610905
- 2031962
- 3010687973
- 8010298
- 8040233
- 1032347
- 1219518
- 2916714
- 3021680161
- 3005809810
- 3009773841
- 2529846
- 3007583964
- 8010694
- 3007648354
- 3007507973
- 9611283
- 8040381
- 3036795921
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 |