The following data is part of a premarket notification filed by Oculab, Inc. with the FDA for Pach-pen Surgical Drape.
| Device ID | K862016 |
| 510k Number | K862016 |
| Device Name: | PACH-PEN SURGICAL DRAPE |
| Classification | Drape, Surgical |
| Applicant | OCULAB, INC. 443 W. COLORADO ST. Glendale, CA 91205 |
| Contact | Wallace, M.d. |
| Correspondent | Wallace, M.d. OCULAB, INC. 443 W. COLORADO ST. Glendale, CA 91205 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-28 |
| Decision Date | 1986-06-04 |