The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for A4907 Lens Cleaning Sheath.
| Device ID | K961860 |
| 510k Number | K961860 |
| Device Name: | A4907 LENS CLEANING SHEATH |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-14 |
| Decision Date | 1996-08-29 |
| Summary: | summary |