The following data is part of a premarket notification filed by Bonasse Ent. Co., Ltd. with the FDA for Bonasse Contact Lens Case.
| Device ID | K991206 |
| 510k Number | K991206 |
| Device Name: | BONASSE CONTACT LENS CASE |
| Classification | Case, Contact Lens |
| Applicant | BONASSE ENT. CO., LTD. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Contact | Milton N Beneke |
| Correspondent | Milton N Beneke BONASSE ENT. CO., LTD. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-09 |
| Decision Date | 2000-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917186792 | K991206 | 000 |
| 04719872850069 | K991206 | 000 |
| 04719872850052 | K991206 | 000 |
| 04719872850038 | K991206 | 000 |
| 04719872850014 | K991206 | 000 |
| 20024291299336 | K991206 | 000 |
| 00024291299332 | K991206 | 000 |
| 00078041200352 | K991206 | 000 |
| 00078041200345 | K991206 | 000 |
| 00078041200338 | K991206 | 000 |
| 00756063059294 | K991206 | 000 |
| 00756063059287 | K991206 | 000 |
| 00756063059263 | K991206 | 000 |
| 04719872850076 | K991206 | 000 |
| 04719872850113 | K991206 | 000 |
| 04719872850137 | K991206 | 000 |
| 10681131248935 | K991206 | 000 |
| 10681131248911 | K991206 | 000 |
| 00681131080972 | K991206 | 000 |
| 10681131080962 | K991206 | 000 |
| 04719872850304 | K991206 | 000 |
| 04719872850298 | K991206 | 000 |
| 04719872850281 | K991206 | 000 |
| 04719872850250 | K991206 | 000 |
| 04719872850243 | K991206 | 000 |
| 04719872850236 | K991206 | 000 |
| 04719872850175 | K991206 | 000 |
| 04719872850168 | K991206 | 000 |
| 10311917011292 | K991206 | 000 |