510(k) K941217
K941217 is an FDA 510(k) premarket notification submitted by Dumex Medical Surgical Products, Ltd. for the device "DUPAQUE SPONGE". The FDA issued a decision of Substantially Equivalent on April 21, 1994. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Dumex Medical Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1994
- Date Received
- March 14, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gauze/Sponge, Internal, X-Ray Detectable
- Device Class
- Class I
- Regulation Number
- 878.4450
- Review Panel
- SU
- Submission Type