The following data is part of a premarket notification filed by Henley Intl. with the FDA for Surgical 'laser' Drape.
| Device ID | K884231 |
| 510k Number | K884231 |
| Device Name: | SURGICAL 'LASER' DRAPE |
| Classification | Drape, Surgical |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | Henley, Phd |
| Correspondent | Henley, Phd HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-07 |
| Decision Date | 1989-04-20 |