The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Buttonhole Needle Sets.
| Device ID | K990803 |
| 510k Number | K990803 |
| Device Name: | MEDISYSTEMS BUTTONHOLE NEEDLE SETS |
| Classification | Needle, Fistula |
| Applicant | MEDISYSTEMS CORP. 1900 K STREET, N.W. Washington, DC 20006 |
| Contact | Larry R Pilot |
| Correspondent | Larry R Pilot MEDISYSTEMS CORP. 1900 K STREET, N.W. Washington, DC 20006 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-10 |
| Decision Date | 2000-01-06 |
| Summary: | summary |