510(k) K921535
K921535 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "SUOENA AFFINITY (TM) MODEL #802". The FDA issued a decision of Substantially Equivalent on May 11, 1992. The device falls under product code KCZ (Prosthesis, Breast, External, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800. Coloplast Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1992
- Date Received
- March 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Breast, External, Used With Adhesive
- Device Class
- Class I
- Regulation Number
- 878.3800
- Review Panel
- SU
- Submission Type