Medline Open End Finger Control Mitt
FDA 510(k) K963504 · Medline
510(k) numberK963504
Submission
- Device name
- Medline Open End Finger Control Mitt
- Applicant
- Medline
Mundelein, IL, US - Received
- September 3, 1996
- Decision date
- October 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMQ – Restraint, Protective
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6760
- Specialty
- General Hospital
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Questions and answers
When was Medline Open End Finger Control Mitt cleared by the FDA?
Medline Open End Finger Control Mitt (K963504) received a 510(k) decision of Substantially Equivalent on October 29, 1996, 56 days after the submission was received.
What is the product code of K963504?
The FDA product code is FMQ – Restraint, Protective, a Class I (low risk) device regulated under 21 CFR 880.6760.