The following data is part of a premarket notification filed by Softchrome, Inc. with the FDA for Softchrome Tints, Transparent Tinted Soft Contact Lens.
| Device ID | K991995 |
| 510k Number | K991995 |
| Device Name: | SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS |
| Classification | System, In-office Tinting, Contact Lenses |
| Applicant | SOFTCHROME, INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing SOFTCHROME, INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | MZD |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-14 |
| Decision Date | 1999-08-27 |
| Summary: | summary |