The following data is part of a premarket notification filed by Good Bond Industrial Corp. with the FDA for Non-prescription Sunglasses.
Device ID | K934461 |
510k Number | K934461 |
Device Name: | NON-PRESCRIPTION SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | GOOD BOND INDUSTRIAL CORP. PEI YUAN ST Tainan, Taiwan, TW |
Contact | Wang Ching-yun |
Correspondent | Wang Ching-yun GOOD BOND INDUSTRIAL CORP. PEI YUAN ST Tainan, Taiwan, TW |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-10 |
Decision Date | 1994-04-06 |