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#
- 3023657851
- 9611112
- 3005440795
- 2518410
- 3007507973
- 3019924
- 3004215117
- 2431166
- 9615857
- 3008828237
- 1421879
- 1056350
- 3008342610
- 3007334784
- 8040278
- 8010099
- 3010041511
- 3035678069
- 3007589150
- 3010687973
- 3009465247
- 1923569
- 3005225959
- 3042228518
- 3008338766
- 2242450
- 9611283
- 1929756
- 3002976036
- 3003039352
- 1313525
- 1222993
- 3010699884
- 8043816
- 3015895045
- 1045379
- 9616245
- 1032347
- 3002675176
- 8040382
- 3006380247
- 3033566
- 3015451162
- 3007583964
- 1450662
- 3006677911
- 1219518
- 3004001706
- 1928237
- 1836161
- 8010694
- 3004571672
- 3029082594
- 3003951061
- 1319639
- 3031231776
- 3013096510
- 1424263
- 1211998
- 2529846
- 8044098
- 3005489143
- 9614107
- 3029990829
- 8043368
- 8040884
- 1720929
- 9616246
- 2434839
- 3015177648
- 9611503
- 3013503739
- 8043235
- 3003418325
- 3017857440
- 3015972897
- 3033536312
- 3013497507
- 8043441
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 |