The following data is part of a premarket notification filed by Swank Plus Ltd. with the FDA for Frame, Spectacle.
Device ID | K873965 |
510k Number | K873965 |
Device Name: | FRAME, SPECTACLE |
Classification | Frame, Spectacle |
Applicant | SWANK PLUS LTD. P.O. BOX 70750 KOWLOON CENTRAL POST OFFICE Hong Kong, HK |
Contact | Cider Lai |
Correspondent | Cider Lai SWANK PLUS LTD. P.O. BOX 70750 KOWLOON CENTRAL POST OFFICE Hong Kong, HK |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-29 |
Decision Date | 1988-04-01 |