The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Balloon Cannula 15mm X 35mm,15mm X 55mm, 10/12mm X 55mm,10/12mm X 35mm,5mm X 35mm,2mm X 35mm.
| Device ID | K960810 |
| 510k Number | K960810 |
| Device Name: | BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM |
| 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 | 1996-02-28 |
| Decision Date | 1996-10-21 |
| Summary: | summary |