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510(k) K770853

STERILE COTTON by Stat Medical Corp. — Product Code FRL

K770853 is an FDA 510(k) premarket notification submitted by Stat Medical Corp. for the device "STERILE COTTON". The FDA issued a decision of Substantially Equivalent on May 23, 1977. The device falls under product code FRL (Fiber, Medical, Absorbent), a Class I device regulated under 21 CFR 880.5300. Stat Medical Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1977
Date Received
May 9, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fiber, Medical, Absorbent
Device Class
Class I
Regulation Number
880.5300
Review Panel
HO
Submission Type

Other clearances by Stat Medical Corp.

  • K780171 — ELBOW PROTECTOR (February 6, 1978)
  • K771030 — FLEXION MITTENS (June 27, 1977)
  • K771031 — STROKE SLING (June 27, 1977)

Other clearances for product code FRL

  • K121898 — STAY FRESH SKIN FOLD MANAGEMENT TEXTILE (May 24, 2013)
  • K110715 — INTERDRY SILVER (November 4, 2011)
  • K061615 — INTERDRY TEXTILE WITH SILVER (December 22, 2006)
  • K931626 — CARAPACE STERILE COTTON BALLS (December 2, 1993)
  • K914081 — ICAN COTTON RAYON BALLS (October 9, 1991)
  • K811990 — TRACH CLEANING TRAY (July 27, 1981)
  • K810242 — UTENSIL & PROCEDURE TRAYS (April 15, 1981)
  • K800277 — MEDSPEC RAYON BALLS (March 12, 1980)
  • K800249 — SURGITEK FOERSTER MAMMARY BANDAGE (February 19, 1980)
  • K800248 — SURGITEK FOERSTER FACE LIFT BANDAGE (February 19, 1980)

FDA data resources