The following data is part of a premarket notification filed by Medical Plastics, Inc. with the FDA for Under Buttocks Drape.
| Device ID | K895404 |
| 510k Number | K895404 |
| Device Name: | UNDER BUTTOCKS DRAPE |
| Classification | Drape, Surgical |
| Applicant | MEDICAL PLASTICS, INC. 1050 NORTHFIELD COURT SUITE 300 Roswell, GA 30076 |
| Contact | Joseph Prince |
| Correspondent | Joseph Prince MEDICAL PLASTICS, INC. 1050 NORTHFIELD COURT SUITE 300 Roswell, GA 30076 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-07 |
| Decision Date | 1989-10-06 |