The following data is part of a premarket notification filed by Heraeus Surgical, Inc. with the FDA for Lasersonics Tissue Morcellator Set.
| Device ID | K935604 |
| 510k Number | K935604 |
| Device Name: | LASERSONICS TISSUE MORCELLATOR SET |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | HERAEUS SURGICAL, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 -7434 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath HERAEUS SURGICAL, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 -7434 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-19 |
| Decision Date | 1994-03-23 |