The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Hx-20/21-1 Endoscopic Ligator.
| Device ID | K964661 |
| 510k Number | K964661 |
| Device Name: | HX-20/21-1 ENDOSCOPIC LIGATOR |
| Classification | Ligator, Esophageal |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Subhash Patel |
| Correspondent | Subhash Patel OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | MND |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-20 |
| Decision Date | 1997-10-30 |
| Summary: | summary |