The following data is part of a premarket notification filed by Acacia Laboratories, Inc. with the FDA for Sterile Plastic Drape.
| Device ID | K913408 |
| 510k Number | K913408 |
| Device Name: | STERILE PLASTIC DRAPE |
| Classification | Drape, Surgical |
| Applicant | ACACIA LABORATORIES, INC. 1010 HATHAWAY AVE. Santa Ana, CA 92705 |
| Contact | William A Goolsbee |
| Correspondent | William A Goolsbee ACACIA LABORATORIES, INC. 1010 HATHAWAY AVE. Santa Ana, CA 92705 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-30 |
| Decision Date | 1992-03-12 |