The following data is part of a premarket notification filed by Marlow Surgical Technologies, Inc. with the FDA for Family Of Primus Forceps: Graspers/dissectors/suturers/needle Drivers.
| Device ID | K944563 |
| 510k Number | K944563 |
| Device Name: | FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | MARLOW SURGICAL TECHNOLOGIES, INC. 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Arthur S Goddard |
| Correspondent | Arthur S Goddard MARLOW SURGICAL TECHNOLOGIES, INC. 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1994-12-27 |