The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Multicath - Code#s 8.1207.oo/8.1208.00/8.1205.20.
Device ID | K870067 |
510k Number | K870067 |
Device Name: | MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20 |
Classification | Catheter, Percutaneous |
Applicant | VYGON CORP. 1 MADISON ST. East Rutherford, NJ 07073 |
Contact | Tony J Rivers |
Correspondent | Tony J Rivers VYGON CORP. 1 MADISON ST. East Rutherford, NJ 07073 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-08 |
Decision Date | 1987-04-28 |