Clear-View Mirror Warmer
FDA 510(k) K800382 · Surgical Mechanical Research, Inc.
510(k) numberK800382
Submission
- Device name
- Clear-View Mirror Warmer
- Applicant
- Surgical Mechanical Research, Inc.
Mchenry, IL, US - Received
- February 22, 1980
- Decision date
- May 14, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GET – Motor, Surgical Instrument, Pneumatic Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K914753 | Auto Suture(R) Articulating Endoscopic ClampGET · Traditional | United States Surgical, A Division of Tyco Healthc | 06/11/1992SE |
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Questions and answers
When was Clear-View Mirror Warmer cleared by the FDA?
Clear-View Mirror Warmer (K800382) received a 510(k) decision of Substantially Equivalent on May 14, 1980, 82 days after the submission was received.
What is the product code of K800382?
The FDA product code is GET – Motor, Surgical Instrument, Pneumatic Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.