The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Equipment Slush Drape.
| Device ID | K053495 |
| 510k Number | K053495 |
| Device Name: | EQUIPMENT SLUSH DRAPE |
| Classification | Drape, Surgical |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 1241 ATLANTA INDUSTRIAL DR. Marietta, GA 30066 |
| Contact | William Slevin |
| Correspondent | William Slevin ADVANCE MEDICAL DESIGNS, INC. 1241 ATLANTA INDUSTRIAL DR. Marietta, GA 30066 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-15 |
| Decision Date | 2006-03-16 |
| Summary: | summary |