The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Yield Tissue Sampler.
Device ID | K090853 |
510k Number | K090853 |
Device Name: | YIELD TISSUE SAMPLER |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | BRONCUS TECHNOLOGIES, INC. 1400 N. SHORELINE BLVD. BLDG A SUITE 8 Mountain Veiw, CA 94043 |
Contact | Nancy Isaac |
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 | 2009-03-30 |
Decision Date | 2009-04-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00856571007210 | K090853 | 000 |
00856571007012 | K090853 | 000 |