The following data is part of a premarket notification filed by Biotronik, Gmbh & Co. with the FDA for A1-a,a1-b,a1-abp,a1-mbp,a1-z,a6-a,a6-b,peh Pace..
| Device ID | K902889 |
| 510k Number | K902889 |
| Device Name: | A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. |
| Classification | Pacemaker Lead Adaptor |
| Applicant | BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
| Contact | Stout, Md |
| Correspondent | Stout, Md BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-02 |
| Decision Date | 1990-08-23 |