510(k) K920169
- Device
- SUNGLASSES
- Applicant
- WALGREEN CO.
- 510(k) number
- K920169
- Product code
- HQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-05-01
- Date received
- 1992-01-13
- 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
- PASQUALE A ZAMBRENO
- Address
- 200 Wilmot Rd. Ms 2254 Deerfield IL US 60015 60015
FDA Registration Numbers#
- 3014161178
- 9615664
- 3030444859
- 1064737
- 3038281008
- 1000467313
- 1000369642
- 3010142106
- 3012995440
- 3004784416
- 3009279940
- 3006203695
- 3009305325
- 3027553893
- 3005309207
- 3014938469
- 3010663789
- 3013293162
- 3009974444
- 9680861
- 3014610509
- 3031118863
- 3013278028
- 3009744245
- 3012937100
- 1000493936
- 1052967
- 3010397989
- 8043173
- 3013556952
- 3007421138
- 3029921664
- 3024987631
- 3012498117
- 3030040625
- 3043088203
- 3009628080
- 3021612330
- 3014220667
- 3010526253
- 3022260441
- 3015282707
- 3008388363
- 3014273526
- 3044301287
- 3012263937
- 3003755663
- 3023876592
- 3002518348
- 3019784546
- 3014016129
- 1937100
- 3013841727
- 3017763244
- 3012202690
- 3012842398
- 3017540740
- 3017180717
- 3005135579
- 3003047821
- 3033818635
- 3013519222
- 3018161205
- 9710499
- 3004129978
- 3008350694
- 9710502
- 2936829
- 3038991271
- 3043179616
- 3013213574
- 1000281480
- 3023265418
- 9615035
- 2432297
- 3011743844
- 3024761170
- 3042970299
- 3004938952
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 |
| K974414 | MULTI | Morning Calm Corp. | 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases