The following data is part of a premarket notification filed by Steri-shield Products, Inc. with the FDA for Ultrasonic Scaler Cover.
| Device ID | K884221 |
| 510k Number | K884221 |
| Device Name: | ULTRASONIC SCALER COVER |
| Classification | Scaler, Ultrasonic |
| Applicant | STERI-SHIELD PRODUCTS, INC. 3620 HAMILTON BLVD. Allentown, PA 18103 |
| Contact | Mark Eisner |
| Correspondent | Mark Eisner STERI-SHIELD PRODUCTS, INC. 3620 HAMILTON BLVD. Allentown, PA 18103 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-06 |
| Decision Date | 1989-03-17 |