The following data is part of a premarket notification filed by Haag-streit Usa, Inc. with the FDA for Haag-streit Contact Glasses Stery Cup, Accessory.
| Device ID | K051103 |
| 510k Number | K051103 |
| Device Name: | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | HAAG-STREIT USA, INC. 7361 CALHOUN PLACE, SUITE 500 Rockville, MD 20855 -2765 |
| Contact | Eduardo March |
| Correspondent | Eduardo March HAAG-STREIT USA, INC. 7361 CALHOUN PLACE, SUITE 500 Rockville, MD 20855 -2765 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-29 |
| Decision Date | 2005-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640132986518 | K051103 | 000 |
| 07640132986365 | K051103 | 000 |
| 07640132986358 | K051103 | 000 |
| 07640132986341 | K051103 | 000 |
| 07640132986334 | K051103 | 000 |
| 07640132986327 | K051103 | 000 |
| 07640132986310 | K051103 | 000 |
| 07640132986303 | K051103 | 000 |
| 07640132986297 | K051103 | 000 |
| 07640132986280 | K051103 | 000 |
| 07640132986273 | K051103 | 000 |
| 07640132986266 | K051103 | 000 |
| 07640132986372 | K051103 | 000 |
| 07640132986389 | K051103 | 000 |
| 07640132986396 | K051103 | 000 |
| 07640132986501 | K051103 | 000 |
| 07640132986495 | K051103 | 000 |
| 07640132986488 | K051103 | 000 |
| 07640132986471 | K051103 | 000 |
| 07640132986464 | K051103 | 000 |
| 07640132986457 | K051103 | 000 |
| 07640132986440 | K051103 | 000 |
| 07640132986433 | K051103 | 000 |
| 07640132986426 | K051103 | 000 |
| 07640132986419 | K051103 | 000 |
| 07640132986402 | K051103 | 000 |
| 07640132981926 | K051103 | 000 |