The following data is part of a premarket notification filed by Medtech Ltd. with the FDA for Intromit Hand Access Port For Hand Assisted Laparoscopic Surgery, Model Fp880-150.
| Device ID | K990663 |
| 510k Number | K990663 |
| Device Name: | INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MEDTECH LTD. 555 13TH ST. N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan MEDTECH LTD. 555 13TH ST. N.W. Washington, DC 20004 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-05-27 |
| Summary: | summary |