The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Safe-cath.
Device ID | K960764 |
510k Number | K960764 |
Device Name: | SAFE-CATH |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
Contact | Richard C Bell |
Correspondent | Richard C Bell SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-26 |
Decision Date | 1997-04-24 |
Summary: | summary |