Intra-Oral Thermoplastic Shield
FDA 510(k) K962622 · Medtec, Inc.
510(k) numberK962622
Submission
- Device name
- Intra-Oral Thermoplastic Shield
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- July 5, 1996
- Decision date
- October 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K955236 | Green TEC-2100IWE · Traditional | 05/24/1996SE |
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Questions and answers
When was Intra-Oral Thermoplastic Shield cleared by the FDA?
Intra-Oral Thermoplastic Shield (K962622) received a 510(k) decision of Substantially Equivalent on October 1, 1996, 88 days after the submission was received.
What is the product code of K962622?
The FDA product code is KPY – Shield, Protective, Personnel, a Class I (low risk) device regulated under 21 CFR 892.6500.