The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Qualtex Needle Counters.
| Device ID | K903947 |
| 510k Number | K903947 |
| Device Name: | QUALTEX NEEDLE COUNTERS |
| Classification | Container, Sharps |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-27 |
| Decision Date | 1990-10-30 |