The following data is part of a premarket notification filed by Gulfstream Medical with the FDA for Sterile Equipment Cover.
| Device ID | K951214 |
| 510k Number | K951214 |
| Device Name: | STERILE EQUIPMENT COVER |
| Classification | Drape, Surgical |
| Applicant | GULFSTREAM MEDICAL 212 WEST CAYAGA DR. Athens, TX 75751 |
| Contact | Alex Withers |
| Correspondent | Alex Withers GULFSTREAM MEDICAL 212 WEST CAYAGA DR. Athens, TX 75751 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-17 |
| Decision Date | 1995-05-16 |