The following data is part of a premarket notification filed by Diamond Mark International Co., Ltd. with the FDA for Sunglasses With Impact Resistant Lenses.
Device ID | K955572 |
510k Number | K955572 |
Device Name: | SUNGLASSES WITH IMPACT RESISTANT LENSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | DIAMOND MARK INTERNATIONAL CO., LTD. HOPING EAST RD., SEC. 3 NO. 238, 10TH FL. Taipei, TW |
Contact | Peggy Lin |
Correspondent | Peggy Lin DIAMOND MARK INTERNATIONAL CO., LTD. HOPING EAST RD., SEC. 3 NO. 238, 10TH FL. Taipei, TW |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-07 |
Decision Date | 1996-01-11 |