The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Marlow/reddick Laparoscopic Grasping Forceps.
Device ID | K913964 |
510k Number | K913964 |
Device Name: | MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS |
Classification | Forceps |
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 | HTD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-05 |
Decision Date | 1991-10-23 |