The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Quick-care Biopsy Needle.
Device ID | K973565 |
510k Number | K973565 |
Device Name: | QUICK-CARE BIOPSY NEEDLE |
Classification | Instrument, Biopsy |
Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
Contact | April Lavender |
Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-19 |
Decision Date | 1997-11-03 |
Summary: | summary |