The following data is part of a premarket notification filed by Biotronik, Gmbh & Co. with the FDA for Lead Terminal Pin Caps, Various Models.
Device ID | K911142 |
510k Number | K911142 |
Device Name: | LEAD TERMINAL PIN CAPS, VARIOUS MODELS |
Classification | Pacemaker Lead Adaptor |
Applicant | BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
Contact | Scott J Mindrebo |
Correspondent | Scott J Mindrebo 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 | 1991-03-14 |
Decision Date | 1991-08-09 |