510(k) K903073
K903073 is an FDA 510(k) premarket notification submitted by Dongkuk Trading Co., Ltd. for the device "LATEX FINGER COTS". The FDA issued a decision of Substantially Equivalent on September 12, 1990. 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
- September 12, 1990
- Date Received
- July 12, 1990
- 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