The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for 3.2-5mm Unipolar Lead Upsizing Kit, Model Ak 100.
Device ID | K900605 |
510k Number | K900605 |
Device Name: | 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 |
Classification | Pacemaker Lead Adaptor |
Applicant | POSSIS MEDICAL, INC. 8325 10TH AVENUE NORTH Minneapolis, MN 55427 |
Contact | Robert J Scott |
Correspondent | Robert J Scott POSSIS MEDICAL, INC. 8325 10TH AVENUE NORTH Minneapolis, MN 55427 |
Product Code | DTD |
CFR Regulation Number | 870.3620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-08 |
Decision Date | 1990-03-06 |