The following data is part of a premarket notification filed by Aesculap Instruments Corp. with the FDA for Elan-e Disposable Drape.
| Device ID | K884057 |
| 510k Number | K884057 |
| Device Name: | ELAN-E DISPOSABLE DRAPE |
| Classification | Drape, Surgical |
| Applicant | AESCULAP INSTRUMENTS CORP. 875 STANTON RD. Burlingame, CA 94010 |
| Contact | Robin Bush |
| Correspondent | Robin Bush AESCULAP INSTRUMENTS CORP. 875 STANTON RD. Burlingame, CA 94010 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-26 |
| Decision Date | 1988-10-19 |