INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
FDA 510(k) clearance K052870 · decided 2006-09-29
Clearance details
- K-number
- K052870
- Device name
- INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
- Applicant
- Kimberly-Clark Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-11
- Decision date
- 2006-09-29
- Days to decision
- 353 days
- Clearance type
- Traditional
- Product code
- NZP
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.