The following data is part of a premarket notification filed by Cardiovascular Group, Inc. with the FDA for Poly-tac.
| Device ID | K882235 |
| 510k Number | K882235 |
| Device Name: | POLY-TAC |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | CARDIOVASCULAR GROUP, INC. POST OFFICE BOX 1954 Lake Oswego, OR 97034 |
| Contact | Joseph M Mertz |
| Correspondent | Joseph M Mertz CARDIOVASCULAR GROUP, INC. POST OFFICE BOX 1954 Lake Oswego, OR 97034 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-27 |
| Decision Date | 1988-10-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() POLY-TAC 74674558 1968470 Dead/Cancelled |
Berspack Industries 1995-05-16 |
![]() POLY-TAC 72192720 0794982 Dead/Expired |
HEYDEN NEWPORT CHEMICAL CORPORATION 1964-05-05 |