The following data is part of a premarket notification filed by Acacia Laboratories, Inc. with the FDA for Newmark(tm) Coronary Artery Bypass Graft Markers.
| Device ID | K892856 |
| 510k Number | K892856 |
| Device Name: | NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| 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 | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-18 |
| Decision Date | 1989-11-08 |