The following data is part of a premarket notification filed by Quantitative Technologies, Inc. with the FDA for The Needle Count And Sharps Disposal System.
| Device ID | K895527 |
| 510k Number | K895527 |
| Device Name: | THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM |
| Classification | Tray, Surgical, Instrument |
| Applicant | QUANTITATIVE TECHNOLOGIES, INC. P.O. BOX 3067 Louisville, KY 40201 |
| Contact | Kelly J Conrad |
| Correspondent | Kelly J Conrad QUANTITATIVE TECHNOLOGIES, INC. P.O. BOX 3067 Louisville, KY 40201 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-12 |
| Decision Date | 1989-10-06 |