510(k) K901882
K901882 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL ENDOSCOPIC LASER OVERTUBE". The FDA issued a decision of Substantially Equivalent on July 27, 1990. The device falls under product code KOQ (Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)), a Class I device regulated under 21 CFR 872.3410. Uresil Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1990
- Date Received
- April 26, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
- Device Class
- Class I
- Regulation Number
- 872.3410
- Review Panel
- DE
- Submission Type