510(k) K974414
- Device
- MULTI
- Applicant
- MORNING CALM CORP.
- 510(k) number
- K974414
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-08
- Date received
- 1997-11-24
- Regulation
- 886.5850
- Classification name
- Sunglasses (non-prescription Including Photosensitive)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALEXANDER B KIM
- Address
- 1106 Seong An Officetel 87-36, Duryu-2dong,Dalseo-Gu Daegu KR
FDA Registration Numbers#
- 3030090215
- 3008421850
- 3006985180
- 3003461935
- 3013338532
- 8031584
- 3013410754
- 3015168505
- 3006026515
- 3023094364
- 3012980312
- 3006391366
- 3014023477
- 3011825032
- 3042870833
- 3008931233
- 3024459439
- 3003837870
- 8020552
- 3014318504
- 3005824979
- 8040222
- 3010774780
- 3004126239
- 3044855013
- 3009317586
- 9710529
- 8040448
- 3013410776
- 3007290476
- 3031606441
- 3008044475
- 3009770970
- 3022260441
- 2319457
- 3013278028
- 3012164338
- 3011248235
- 3009494404
- 3025590466
- 3042228518
- 2432297
- 3005186804
- 3038289343
- 3013819854
- 3010364601
- 3002719961
- 3011277099
- 3013199957
- 3012261167
- 9616939
- 3005982781
- 3007165203
- 3004007442
- 3006347596
- 3027517712
- 3017865175
- 3011770145
- 3042285066
- 3026840430
- 1000481099
- 3006891799
- 3013462840
- 3016452982
- 3005519018
- 3007065619
- 3011786416
- 3011512125
- 3014466582
- 2084271
- 3027321376
- 3008755352
- 3007674720
- 3045030541
- 3018153150
- 3011219231
- 9680369
- 3025349188
- 1720839
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974852 | NON-PRESCRIPTION SUNGLASSES | Chia Hui Spectacles Mfg. Corp. | 1998-01-30 |
| K974860 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Ming Ming Optical Co. , Ltd. | 1998-01-30 |
| K974861 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Hindar Optical Co., Ltd. | 1998-01-27 |
| K974511 | SUNGLASSES | Sun World Intl., Inc. | 1998-01-12 |
| K974441 | SUNGLASSES | Hip Shing Fat Co., Ltd. | 1998-01-09 |
| K973528 | SUNGLASSES | Jeou Jeou Long Industrial Co., Ltd. | 1997-12-08 |
| K974179 | NON-PRESCRIPTION SUNGLASSES | Taipan Optical Company , Ltd. | 1997-12-01 |
| K974045 | VENNETO | Amsure Sports, Inc. | 1997-11-20 |
| K973934 | SUNGLASSES | Elegance Optical Manufactory, Ltd. | 1997-11-18 |
| K973526 | SUNGLASSES | Pyramid Handbags, Inc. | 1997-10-16 |
| K973407 | SUNGLASSES (NON-PRESCRIPTION) | Pacific Optical Co. , Ltd. | 1997-09-30 |
| K973490 | SUNGLASSES | Tong Yang Optical Co. | 1997-09-30 |
| K972850 | SUNGLASSES | Indoptica, S.A. | 1997-09-17 |
| K973016 | NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS | Optimaxx Intl. | 1997-09-17 |
| K972717 | RUFF WORK EYEGEAR | Ruff House, Inc. | 1997-08-25 |
Legacy Summary#
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FDA Review#
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