The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Subcutaneous Endoscopy System.
| Device ID | K963184 |
| 510k Number | K963184 |
| Device Name: | OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-14 |
| Decision Date | 1996-12-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170025990 | K963184 | 000 |
| 04953170025976 | K963184 | 000 |