The following data is part of a premarket notification filed by Laser Spectrum, Inc. with the FDA for Daniell Dbl Puncture Laser Laparoscopy.
| Device ID | K842498 |
| 510k Number | K842498 |
| Device Name: | DANIELL DBL PUNCTURE LASER LAPAROSCOPY |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | LASER SPECTRUM, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-26 |
| Decision Date | 1984-09-25 |