510(k) K982818
K982818 is an FDA 510(k) premarket notification submitted by Gambro Healthcare for the device "HOSPAL TIPSTOP". The FDA issued a decision of Substantially Equivalent on October 21, 1998. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Gambro Healthcare has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1998
- Date Received
- August 11, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Liquid
- Device Class
- Class I
- Regulation Number
- 880.5090
- Review Panel
- SU
- Submission Type