The following data is part of a premarket notification filed by Manan Manufacturing Co., Inc. with the FDA for Manan Ubk Ultrasonic Guided Biopsy Kit.
| Device ID | K852105 |
| 510k Number | K852105 |
| Device Name: | MANAN UBK ULTRASONIC GUIDED BIOPSY KIT |
| Classification | Tray, Biopsy, Without Biopsy Instruments |
| Applicant | MANAN MANUFACTURING CO., INC. 8020 NORTH CENTRAL PARK AVE. Skokie, IL 60076 |
| Contact | Manfred Mittermeier |
| Correspondent | Manfred Mittermeier MANAN MANUFACTURING CO., INC. 8020 NORTH CENTRAL PARK AVE. Skokie, IL 60076 |
| Product Code | FCH |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-15 |
| Decision Date | 1985-06-18 |