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#
- 8040382
- 3005225959
- 3009465247
- 3042100830
- 8040381
- 8043816
- 9611278
- 3003431869
- 3030451558
- 2020550
- 3007583964
- 3012185136
- 8040884
- 3011137372
- 9616250
- 8040278
- 1929756
- 3003435550
- 1319639
- 3006550126
- 9680620
- 3004215117
- 8010547
- 3005809810
- 3010155661
- 3013503739
- 3009027787
- 3005489143
- 9611112
- 3015972897
- 1928237
- 8010298
- 1058726
- 3006380247
- 1934420
- 9612075
- 2916714
- 3010699884
- 9613079
- 3008902714
- 3045853999
- 8043441
- 8010694
- 3015895045
- 3013096510
- 1421879
- 3004475955
- 1720929
- 1836161
- 3010687973
- 3013576617
- 3003803182
- 3008342610
- 3029754081
- 8010099
- 3004001706
- 3017857440
- 3008770252
- 3007317099
- 3009773841
- 2242450
- 1219518
- 9680718
- 3011371465
- 3007589150
- 3014334038
- 3042940336
- 1424263
- 3017367014
- 1450662
- 3020723591
- 3032747418
- 3002976036
- 3004608878
- 3004571672
- 3010041511
- 3010202439
- 3005973280
- 3013602181
- 3016965929
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 |