The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Double Puncture Instruments.
| Device ID | K852901 |
| 510k Number | K852901 |
| Device Name: | DOUBLE PUNCTURE INSTRUMENTS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | LASER, INC. P.O. BOX 358 Tomball, TX 77375 |
| Contact | Wm.(bill) Przybyla |
| Correspondent | Wm.(bill) Przybyla LASER, INC. P.O. BOX 358 Tomball, TX 77375 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-10-16 |