510(k) K853822
K853822 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "AMOENA BREAST FORMS". The FDA issued a decision of Substantially Equivalent on September 30, 1985. The device falls under product code GBI (Material, External Aesthetic Restoration, 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
- September 30, 1985
- Date Received
- September 13, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, External Aesthetic Restoration, Used With Adhesive
- Device Class
- Class I
- Regulation Number
- 878.3800
- Review Panel
- SU
- Submission Type