The following data is part of a premarket notification filed by Swank Plus Ltd. with the FDA for Spectacle, Magnifying.
Device ID | K873967 |
510k Number | K873967 |
Device Name: | SPECTACLE, MAGNIFYING |
Classification | Aid, Vision Image Intensification |
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 | HOT |
CFR Regulation Number | 886.5910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-29 |
Decision Date | 1988-02-26 |