510(k) K982234
K982234 is an FDA 510(k) premarket notification submitted by Innovative Technologies , Ltd. for the device "AL-GEN CALCIUM ALGINATE DRESSING". The FDA issued a decision of Substantially Equivalent on September 8, 1998. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Innovative Technologies , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1998
- Date Received
- June 25, 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