The following data is part of a premarket notification filed by Sharn, Inc. with the FDA for Vila-cooke(tm) Anesthesia Pillow.
| Device ID | K932305 |
| 510k Number | K932305 |
| Device Name: | VILA-COOKE(TM) ANESTHESIA PILLOW |
| Classification | Support, Patient Position |
| Applicant | SHARN, INC. 4801 GEORGE RD., #180 Tampa, FL 33634 |
| Contact | John F Spangler |
| Correspondent | John F Spangler SHARN, INC. 4801 GEORGE RD., #180 Tampa, FL 33634 |
| Product Code | CCX |
| CFR Regulation Number | 868.6820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-12 |
| Decision Date | 1993-10-05 |