510(k) K802248
K802248 is an FDA 510(k) premarket notification submitted by Unoplast A/S for the device "DISARP ORIGINAL". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code GAO (Suture, Nonabsorbable), a Class II device regulated under 21 CFR 878.4495. Unoplast A/S has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1980
- Date Received
- September 16, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable
- Device Class
- Class II
- Regulation Number
- 878.4495
- Review Panel
- SU
- Submission Type