Protectoral Ultrasonic Handpiece Processor
FDA 510(k) K932333 · Gull Laboratories, Inc.
510(k) numberK932333
Submission
- Device name
- Protectoral Ultrasonic Handpiece Processor
- Applicant
- Gull Laboratories, Inc.
Salt Lake City, UT, US - Received
- May 13, 1993
- Decision date
- August 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K940093 | Ebv-Ea(D) Igg Elisa TestLSE · Traditional | 09/15/1995SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | 08/24/1995SE |
| K941198 | Ebv LGG Elisa TestLSE · Traditional | 08/23/1995SE |
| K941624 | Rubella Igg Elisa TestLFX · Traditional | 08/04/1995SE |
| K922759 | HSV-2 Igm Elisa Test--ModificationLGC · Traditional | 10/05/1992SE |
| K922758 | HSV-1 Igm Elisa Test -- ModificationLGC · Traditional | 10/05/1992SE |
Questions and answers
When was Protectoral Ultrasonic Handpiece Processor cleared by the FDA?
Protectoral Ultrasonic Handpiece Processor (K932333) received a 510(k) decision of Substantially Equivalent on August 15, 1995, 824 days after the submission was received.
What is the product code of K932333?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.