The following data is part of a premarket notification filed by Apex Optical Ind. Co. with the FDA for Apex Optical Ind. Co., Eye Wea Models.
Device ID | K932821 |
510k Number | K932821 |
Device Name: | APEX OPTICAL IND. CO., EYE WEA MODELS |
Classification | Frame, Spectacle |
Applicant | APEX OPTICAL IND. CO. RM 302,3/F,SHIN HWA BLDG. 75-6,SUNGDANG-DONG,DALSEU-KU Daegu, Korea, KP |
Contact | Lee |
Correspondent | Lee APEX OPTICAL IND. CO. RM 302,3/F,SHIN HWA BLDG. 75-6,SUNGDANG-DONG,DALSEU-KU Daegu, Korea, KP |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-09 |
Decision Date | 1994-01-25 |