The following data is part of a premarket notification filed by Intermedics Intraocular, Inc. with the FDA for Inter-sharp.
| Device ID | K862070 |
| 510k Number | K862070 |
| Device Name: | INTER-SHARP |
| Classification | Dilator, Lachrymal |
| Applicant | INTERMEDICS INTRAOCULAR, INC. 2650 EAST FOOTHILL BLVD. P.O. BOX 70670 Pasadena, CA 91107 |
| Contact | Enid Rokaw |
| Correspondent | Enid Rokaw INTERMEDICS INTRAOCULAR, INC. 2650 EAST FOOTHILL BLVD. P.O. BOX 70670 Pasadena, CA 91107 |
| Product Code | HNW |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-30 |
| Decision Date | 1986-06-17 |