The following data is part of a premarket notification filed by Telectronics Pacing Systems, Inc. with the FDA for Bifurcated Lead Adaptors, 3.2mm & 5.0 Mm.
| Device ID | K934899 |
| 510k Number | K934899 |
| Device Name: | BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM |
| Classification | Pacemaker Lead Adaptor |
| Applicant | TELECTRONICS PACING SYSTEMS, INC. 1140 NINETEENTH STREET, NW Washington, DC 20036 |
| Contact | Candance F Howell |
| Correspondent | Candance F Howell TELECTRONICS PACING SYSTEMS, INC. 1140 NINETEENTH STREET, NW Washington, DC 20036 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-14 |
| Decision Date | 1994-05-12 |