510(k) K811754
K811754 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "CRYSTONA". The FDA issued a decision of Substantially Equivalent on July 20, 1981. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1981
- Date Received
- June 22, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Cast
- Device Class
- Class I
- Regulation Number
- 890.3025
- Review Panel
- PM
- Submission Type