The following data is part of a premarket notification filed by Acacia Laboratories, Inc. with the FDA for Surgi-tag(tm) Sterile Label Sets.
| Device ID | K884055 |
| 510k Number | K884055 |
| Device Name: | SURGI-TAG(TM) STERILE LABEL SETS |
| Classification | Label Or Tag, Sterile |
| Applicant | ACACIA LABORATORIES, INC. 1010 HATHAWAY AVE. Santa Ana, CA 92705 |
| Contact | A Goolsbee |
| Correspondent | A Goolsbee ACACIA LABORATORIES, INC. 1010 HATHAWAY AVE. Santa Ana, CA 92705 |
| Product Code | LYV |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-26 |
| Decision Date | 1988-10-13 |