The following data is part of a premarket notification filed by Prosben, Inc. with the FDA for Prosben Contact Lens Cases Model Ca66-02, Ca66-03wb, Ca66-04t Series.
Device ID | K122700 |
510k Number | K122700 |
Device Name: | PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES |
Classification | Case, Contact Lens |
Applicant | PROSBEN, INC. 11 F., NO. 58, SEC. 3 MINGCHAUN EAST ROAD Taipei, TW 104 |
Contact | Jen Ke-min |
Correspondent | Jen Ke-min PROSBEN, INC. 11 F., NO. 58, SEC. 3 MINGCHAUN EAST ROAD Taipei, TW 104 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-04 |
Decision Date | 2013-05-31 |
Summary: | summary |