MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)
FDA 510(k) clearance K133934 · decided 2014-05-02
Clearance details
- K-number
- K133934
- Device name
- MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)
- Applicant
- Links Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-23
- Decision date
- 2014-05-02
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Laguna Niguel, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.