The following data is part of a premarket notification filed by Broncus Medical Inc with the FDA for Lungpoint Tools (lungpoint Sheath, Lungpoint Dilation Balloon).
Device ID | K131234 |
510k Number | K131234 |
Device Name: | LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | BRONCUS MEDICAL INC 1400 N. Shoreline Blvd., Bldg A, Suite 8 Mountain View, CA 94043 |
Contact | Mahtab Fatemi |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-05-01 |
Decision Date | 2013-10-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00856571007234 | K131234 | 000 |
00856571007074 | K131234 | 000 |
00856571007067 | K131234 | 000 |
00856571007029 | K131234 | 000 |
00856571007296 | K131234 | 000 |