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510(k) K800248

SURGITEK FOERSTER FACE LIFT BANDAGE by Medical Engineering Corp. — Product Code FRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1980
Date Received
February 6, 1980
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

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  • K902773 — SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET (July 16, 1990)
  • K884746 — SURGITEK FLAT T-SPAN (August 10, 1989)
  • K883274 — SURGITEK (R) UROFLOW SYSTEM (February 8, 1989)
  • K881736 — SURGITEK CO2 DELIVERY SYSTEM (August 11, 1988)
  • K880802 — SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 (May 26, 1988)
  • K880801 — SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 (May 26, 1988)
  • K842748 — SURGITEK RECONSTRUC-NIPPLE PROSTHESIS (September 26, 1984)

Other clearances for product code FRL

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  • 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)
  • K792295 — SORBIES (December 20, 1979)