The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson Transrectal Needle Guide For Intra. Appli..
Device ID | K882549 |
510k Number | K882549 |
Device Name: | ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. |
Classification | Biopsy Needle |
Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Contact | Robert J Gallagher |
Correspondent | Robert J Gallagher ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Product Code | FCG |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-20 |
Decision Date | 1988-07-21 |