The following data is part of a premarket notification filed by Manan Manufacturing Co., Inc. with the FDA for Naman Potts Cournand Needle.
| Device ID | K851832 |
| 510k Number | K851832 |
| Device Name: | NAMAN POTTS COURNAND NEEDLE |
| 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 |