510(k) K884713
K884713 is an FDA 510(k) premarket notification submitted by Primrose Medical, Inc. for the device "COLONIC BALLOON DIALATORS". The FDA issued a decision of Substantially Equivalent on September 29, 1989. The device falls under product code FFP (Dilator, Rectal), a Class I device regulated under 21 CFR 876.5450. Primrose Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1989
- Date Received
- November 8, 1988
- 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