510(k) K901426
K901426 is an FDA 510(k) premarket notification submitted by Telemed Systems, Inc. for the device "COLONIC BALLOON DILATOR". The FDA issued a decision of Substantially Equivalent on June 21, 1990. The device falls under product code FFP (Dilator, Rectal), a Class I device regulated under 21 CFR 876.5450. Telemed Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1990
- Date Received
- March 26, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Rectal
- Device Class
- Class I
- Regulation Number
- 876.5450
- Review Panel
- GU
- Submission Type