510(k) K832908
K832908 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "COMFEEL PROTECTIVE RINGS". The FDA issued a decision of Substantially Equivalent on December 12, 1983. The device falls under product code EYF (Protector, Wound, Plastic), a Class I device regulated under 21 CFR 878.4014. Coloplast A/S has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1983
- Date Received
- August 29, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Wound, Plastic
- Device Class
- Class I
- Regulation Number
- 878.4014
- Review Panel
- SU
- Submission Type