510(k) K912042
K912042 is an FDA 510(k) premarket notification submitted by Bethel Latex Products, Inc. for the device "BETHEL PLUS MULTIPLE NAMES". The FDA issued a decision of Substantially Equivalent on July 2, 1991. The device falls under product code LZB (Finger Cot), a Class I device regulated under 21 CFR 880.6250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 1991
- Date Received
- May 8, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Finger Cot
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type