The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Marlow/reddick Laparoscopic Needle Holders.
| Device ID | K913954 |
| 510k Number | K913954 |
| Device Name: | MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Scott C Marlow |
| Correspondent | Scott C Marlow MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-05 |
| Decision Date | 1991-12-18 |