The following data is part of a premarket notification filed by Stackhouse Assoc. with the FDA for Modified Biovac:lfa Laser Fume Evacuation System.
| Device ID | K874512 |
| 510k Number | K874512 |
| Device Name: | MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | STACKHOUSE ASSOC. BOX 164 Manhattan Beach, CA 90266 |
| Contact | H Stackhouse |
| Correspondent | H Stackhouse STACKHOUSE ASSOC. BOX 164 Manhattan Beach, CA 90266 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-02 |
| Decision Date | 1988-01-27 |