The following data is part of a premarket notification filed by Inlet Medical, Inc. with the FDA for Metra Ps Procedure Kit.
| Device ID | K984600 |
| 510k Number | K984600 |
| Device Name: | METRA PS PROCEDURE KIT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INLET MEDICAL, INC. 2400 CRITTENDEN DR. Louisville, KY 40217 |
| Contact | Mark Sterrett |
| Correspondent | Mark Sterrett INLET MEDICAL, INC. 2400 CRITTENDEN DR. Louisville, KY 40217 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-28 |
| Decision Date | 1999-06-03 |
| Summary: | summary |