The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Contact Nd:yag Laser For Treatment Of Menorrhagia.
| Device ID | K872253 |
| 510k Number | K872253 |
| Device Name: | CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Gifford, R.n. |
| Correspondent | Gifford, R.n. SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-20 |
| Decision Date | 1987-10-06 |