The following data is part of a premarket notification filed by Martech Medical Products, Inc. with the FDA for Martech Endoscopic Injection Needle.
| Device ID | K960519 |
| 510k Number | K960519 |
| Device Name: | MARTECH ENDOSCOPIC INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | MARTECH MEDICAL PRODUCTS, INC. 1500 DELP DR. Harleysville, PA 19438 |
| Contact | David Roberts |
| Correspondent | David Roberts MARTECH MEDICAL PRODUCTS, INC. 1500 DELP DR. Harleysville, PA 19438 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-05 |
| Decision Date | 1996-05-01 |
| Summary: | summary |