The following data is part of a premarket notification filed by Louisville Laboratories, Inc. with the FDA for Carter-thomason Needle-point Suture Passer Instrument Set.
| Device ID | K980123 |
| 510k Number | K980123 |
| Device Name: | CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. Louisville, KY 40217 -1865 |
| Contact | Mark Sterrett |
| Correspondent | Mark Sterrett LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. Louisville, KY 40217 -1865 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-14 |
| Decision Date | 1998-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937002991 | K980123 | 000 |
| 20888937027031 | K980123 | 000 |
| 20888937027055 | K980123 | 000 |
| 20888937027062 | K980123 | 000 |
| 20888937003004 | K980123 | 000 |
| 20888937002946 | K980123 | 000 |
| 20888937002953 | K980123 | 000 |
| 20888937000096 | K980123 | 000 |
| 20888937002892 | K980123 | 000 |
| 20888937002908 | K980123 | 000 |
| 20888937002915 | K980123 | 000 |
| 20888937002922 | K980123 | 000 |
| 20888937002939 | K980123 | 000 |
| 20888937002960 | K980123 | 000 |
| 20888937002977 | K980123 | 000 |
| 20888937002984 | K980123 | 000 |
| 00888937027044 | K980123 | 000 |