510(k) K990042
K990042 is an FDA 510(k) premarket notification submitted by Bio Med Sciences, Inc. for the device "SILON DUAL-DRESS". The FDA issued a decision of Substantially Equivalent on March 19, 1999. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Bio Med Sciences, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1999
- Date Received
- January 6, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type