The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Clarke Laparoscopic Ligator And Forceps.
| Device ID | K903560 |
| 510k Number | K903560 |
| Device Name: | CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | C Marlow |
| Correspondent | C Marlow 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 | 1990-08-08 |
| Decision Date | 1990-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937011449 | K903560 | 000 |
| 00888937011432 | K903560 | 000 |
| 00888937011425 | K903560 | 000 |
| 00888937011395 | K903560 | 000 |