The following data is part of a premarket notification filed by Reichert, Inc. with the FDA for Modification To: Ocu-film Tip Cover.
| Device ID | K070534 |
| 510k Number | K070534 |
| Device Name: | MODIFICATION TO: OCU-FILM TIP COVER |
| Classification | Tonometer, Manual |
| Applicant | REICHERT, INC. 3362 WALDEN AVE. Depew, NY 14043 |
| Contact | Sandra Brown |
| Correspondent | Sandra Brown REICHERT, INC. 3362 WALDEN AVE. Depew, NY 14043 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-26 |
| Decision Date | 2007-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812559012096 | K070534 | 000 |
| 00812559012089 | K070534 | 000 |
| 00812559010115 | K070534 | 000 |