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510(k) K083354

FLORASEAL, MODEL FS350D by Adhezion Biomedical — Product Code NZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2009
Date Received
November 13, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Microbial
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.

Other clearances by Adhezion Biomedical

  • K223669 — SecurePortIV Advanced Catheter Securement Adhesive (June 12, 2023)
  • K170505 — SecurePortIV Catheter Securement Adhesive (September 29, 2017)
  • K161011 — SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISE (November 8, 2016)
  • K150866 — SURGISEAL Topical Skin Adhesvie (July 17, 2015)
  • K133963 — SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE (September 9, 2014)
  • K141215 — SURGISEAL TWIST TOPICAL SKIN ADHESIVE (August 21, 2014)
  • K140517 — SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE (April 28, 2014)
  • K130329 — SURGISEAL TOPICAL SKIN ADHESIVE (December 3, 2013)
  • K130474 — SURGISEAL TOPICAL SKIN ADHESIVE (May 31, 2013)
  • K123936 — SURGISEAL TOPICAL SKIN ADHESIVE (April 24, 2013)

Other clearances for product code NZP

  • K223669 — SecurePortIV Advanced Catheter Securement Adhesive (June 12, 2023)
  • K170505 — SecurePortIV Catheter Securement Adhesive (September 29, 2017)
  • K052870 — INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 (September 29, 2006)