The following data is part of a premarket notification filed by Good Bond Industrial Corp. with the FDA for Spectacle Frame.
Device ID | K934463 |
510k Number | K934463 |
Device Name: | SPECTACLE FRAME |
Classification | Frame, Spectacle |
Applicant | GOOD BOND INDUSTRIAL CORP. NO. 17, ALLEY 171, LANE 87, PEI YUAN STREET Tainan, TW |
Contact | Wang Ching-yun |
Correspondent | Wang Ching-yun GOOD BOND INDUSTRIAL CORP. NO. 17, ALLEY 171, LANE 87, PEI YUAN STREET Tainan, TW |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-10 |
Decision Date | 1993-12-08 |