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510(k) K933228

KAPTON PEEL POUCH by American Fluoroseal Corp. — Product Code KJA

K933228 is an FDA 510(k) premarket notification submitted by American Fluoroseal Corp. for the device "KAPTON PEEL POUCH". The FDA issued a decision of Substantially Equivalent on March 30, 1994. The device falls under product code KJA (Flask, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. American Fluoroseal Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1994
Date Received
July 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flask, Tissue Culture
Device Class
Class I
Regulation Number
864.2240
Review Panel
PA
Submission Type

Other clearances by American Fluoroseal Corp.

  • K870865 — TISSUE CULTURE BAG (March 30, 1987)

Other clearances for product code KJA

  • K972404 — VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) (July 22, 1997)
  • K885121 — CELL SCRAPER (December 28, 1988)
  • K873890 — TISSUE CULTURE FLASKS (November 25, 1987)
  • K873889 — TISSUE CULTURE TUBES (November 25, 1987)
  • K871324 — DU PONT STERICELL CELL CULTURE SYSTEM (April 14, 1987)
  • K870865 — TISSUE CULTURE BAG (March 30, 1987)
  • K864021 — TISSUE CULTURE FLASK (October 29, 1986)
  • K862152 — TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD (June 16, 1986)
  • K861253 — TISSUE CULTURE FLASK PL 732 PLASTIC (April 11, 1986)
  • K853441 — FETAL BOVINE SERUM IN TRANSFER CONTAINER (August 26, 1985)

FDA data resources