510(k) K941391
K941391 is an FDA 510(k) premarket notification submitted by Innovatec Medical Corp. for the device "INFLATABLE RETENTION CUFF SPECULUM". The FDA issued a decision of Substantially Equivalent on October 20, 1994. The device falls under product code GBT (Catheter, Rectal), a Class II device regulated under 21 CFR 876.5980.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1994
- Date Received
- March 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Rectal
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type