The following data is part of a premarket notification filed by Manan Manufacturing Co., Inc. with the FDA for Manan Gwi Guide Wire Introducer.
| Device ID | K851834 |
| 510k Number | K851834 |
| Device Name: | MANAN GWI GUIDE WIRE INTRODUCER |
| Classification | Instruments, Surgical, Cardiovascular |
| 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 | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-26 |
| Decision Date | 1985-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50884908105280 | K851834 | 000 |
| 20859013006110 | K851834 | 000 |
| 20859013006127 | K851834 | 000 |
| 20859013006158 | K851834 | 000 |
| 20859013006165 | K851834 | 000 |
| 20859013006172 | K851834 | 000 |
| 20859013006189 | K851834 | 000 |
| 50884908028787 | K851834 | 000 |
| 50884908028817 | K851834 | 000 |
| 50884908029685 | K851834 | 000 |
| 20859013006103 | K851834 | 000 |