The following data is part of a premarket notification filed by Cook Endoscopy with the FDA for Echotip Ultra Ultrasound Needle.
Device ID | K083330 |
510k Number | K083330 |
Device Name: | ECHOTIP ULTRA ULTRASOUND NEEDLE |
Classification | Biopsy Needle |
Applicant | COOK ENDOSCOPY 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
Contact | Scottie Fariole |
Correspondent | Scottie Fariole COOK ENDOSCOPY 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
Product Code | FCG |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-12 |
Decision Date | 2009-02-06 |
Summary: | summary |