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#
- 3013503739
- 1720929
- 3021680161
- 3005528784
- 9617768
- 9616250
- 9610905
- 3029754081
- 1928237
- 3036795921
- 3011371465
- 8043368
- 3005440795
- 3033536312
- 3007589150
- 9614107
- 3019924
- 8040382
- 8043441
- 3004608878
- 3033566
- 9615659
- 3007648354
- 1934420
- 2242450
- 3012995405
- 9611112
- 3005225959
- 3003803182
- 2529846
- 8010374
- 1929756
- 1923569
- 3005809810
- 3045853999
- 9610612
- 8010099
- 8010298
- 3003431869
- 3000264417
- 3009773841
- 3011110913
- 3004475955
- 3042228518
- 1032347
- 3011137372
- 3003039352
- 3029990829
- 8010376
- 3007334784
- 3013938829
- 3007317099
- 3004552850
- 3004571672
- 8010665
- 1932180
- 3017857440
- 3005067367
- 3031231776
- 9710524
- 3015972897
- 2431166
- 8043816
- 9611278
- 1211998
- 3006550126
- 8040884
- 3004001706
- 3029082594
- 1219518
- 3008338766
- 8040381
- 3010041511
- 2032098
- 3022862651
- 1935627
- 3010155661
- 8010547
- 3004215117
- 8043769
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 |