The following data is part of a premarket notification filed by Angiosystems, Inc. with the FDA for Sterile Disposable Drape/ophthalmic Surgery.
| Device ID | K905460 |
| 510k Number | K905460 |
| Device Name: | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY |
| Classification | Drape, Patient, Ophthalmic |
| Applicant | ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Contact | Alan P Scwartz |
| Correspondent | Alan P Scwartz ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Product Code | HMT |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-05 |
| Decision Date | 1991-02-06 |