MEPILEX
FDA 510(k) clearance K983184 · decided 1998-10-28
Clearance details
- K-number
- K983184
- Device name
- MEPILEX
- Applicant
- Molnlycke Health Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-11
- Decision date
- 1998-10-28
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- MGP
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Eddystone, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.