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 |