The following data is part of a premarket notification filed by Std Mfg., Inc. with the FDA for Suction Vascular Stapler And Implantable Staple System.
| Device ID | K000608 |
| 510k Number | K000608 |
| Device Name: | SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM |
| Classification | Staple, Implantable |
| Applicant | STD MFG., INC. 1063 TURNPIKE ST. P.O. BOX 420 Stoughton, MA 02072 |
| Contact | Jim Lousararian |
| Correspondent | Jim Lousararian STD MFG., INC. 1063 TURNPIKE ST. P.O. BOX 420 Stoughton, MA 02072 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-23 |
| Decision Date | 2000-03-07 |