The following data is part of a premarket notification filed by Acacia Laboratories, Inc. with the FDA for Newchill(tm) Cardiac Insulator.
| Device ID | K892804 |
| 510k Number | K892804 |
| Device Name: | NEWCHILL(TM) CARDIAC INSULATOR |
| Classification | Instruments, Surgical, Cardiovascular |
| 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 | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-17 |
| Decision Date | 1989-07-14 |