The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Nu-tip(tm) Forceps:graspers/dissectors/sutures.
| Device ID | K932634 |
| 510k Number | K932634 |
| Device Name: | NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Arthur S Goddard |
| Correspondent | Arthur S Goddard MARLO SURGICAL TECHNOLOGY 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 | 1993-06-02 |
| Decision Date | 1994-02-25 |