The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Expect Slimline Endoscopic Ultrasound Aspiration Needle.
Device ID | K133312 |
510k Number | K133312 |
Device Name: | EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE |
Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
Applicant | Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
Contact | Yingying Gao |
Correspondent | Yingying Gao Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
Product Code | ODG |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-28 |
Decision Date | 2014-01-03 |
Summary: | summary |