510(k) K013525
K013525 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)". The FDA issued a decision of Substantially Equivalent on October 4, 2002. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Coloplast Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 2002
- Date Received
- October 23, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type