The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Ideas Occluder.
Device ID | K935964 |
510k Number | K935964 |
Device Name: | IDEAS OCCLUDER |
Classification | Clamp, Vascular |
Applicant | IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Contact | Lorna K Linville |
Correspondent | Lorna K Linville IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-13 |
Decision Date | 1995-01-04 |