510(k) K022373
- Device
- CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
- Applicant
- CANTOR & NISSEL LTD.
- 510(k) number
- K022373
- Product code
- NJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-07
- Date received
- 2002-07-22
- Regulation
- 886.5844
- Classification name
- Lens, Spectacle (prescription), For Reading Discomfort
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN DALSING
- Address
- 623 Glacier Dr. Grand Junction CO US 81503 81503
FDA Registration Numbers#
- 3004625743
- 3026654653
- 3007886982
- 3009761494
- 3034629647
- 3014444068
- 3009981789
- 3017953755
- 3017296478
- 3009093215
- 3007801751
- 3007817071
- 3013532963
- 3018153150
- 3003325113
- 8043274
- 3014518341
- 3008164710
- 3005094451
- 3011219231
- 3033790358
- 3044735884
- 3023266994
- 3044465767
- 3006985123
- 3042895304
- 3031182194
- 3014020412
- 3020386049
- 3019021940
- 3030040625
- 3009218098
- 3014530379
- 3033818635
- 3044688589
- 3030194786
- 9614310
- 3031590635
- 3015112437
- 3016159209
- 3012981754
- 3016929296
- 3016870766
- 3026877878
- 3030434441
- 3007774468
- 3018074459
- 3010170531
- 3012748937
- 9616922
- 3043750614
- 3040999150
- 3015248743
- 3009762272
- 3019009783
- 3014326859
- 3017649333
- 3004134915
- 3011248235
- 3027556697
- 3009744245
- 3013510936
- 3044779075
- 3022808
- 3009491490
- 3016170487
- 3012433574
- 3032027177
- 3038134332
- 3012995440
- 3011307306
- 3017180721
- 3025350033
- 3030643434
- 3005499942
- 3003449465
- 3029968417
- 3027209650
- 3026979361
Source Documents#
Other 510(k) Records For Product Code NJH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K853758 | PY-RITE | Golden Dental Products, Inc. | 1985-12-03 |
Legacy Summary#
summary
FDA Review#
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