The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Ideas' Dual Port.
Device ID | K962751 |
510k Number | K962751 |
Device Name: | IDEAS' DUAL PORT |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Contact | Elizabeth M Paul |
Correspondent | Elizabeth M Paul IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-15 |
Decision Date | 1996-09-30 |
Summary: | summary |