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510(k) K792211

SPECIMAN CUP & EMESIS BASIN by General Clinical Plastics Corp. — Product Code FMH

K792211 is an FDA 510(k) premarket notification submitted by General Clinical Plastics Corp. for the device "SPECIMAN CUP & EMESIS BASIN". The FDA issued a decision of Substantially Equivalent on November 16, 1979. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. General Clinical Plastics Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1979
Date Received
November 2, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
HO
Submission Type

Other clearances by General Clinical Plastics Corp.

  • K791348 — ROUND WASHBASIN & RECTANGLE WASHBASIN (September 17, 1979)
  • K791345 — MEDICINE CUP (August 3, 1979)
  • K791346 — DISPOSABLE BEDPAN (August 3, 1979)

Other clearances for product code FMH

  • K900983 — TRI-TECH URINE SPECIMEN KIT (September 17, 1990)
  • K823763 — VARIOUS-SPECIMEN COLLECTORS (January 19, 1983)
  • K820180 — CALCULI FILTER CUP (February 5, 1982)
  • K812933 — LANCER SPECIMEN CONTAINER (November 6, 1981)
  • K802340 — SPECIMEN SET (October 10, 1980)
  • K802002 — URINE SPECIMEN CONTAINER #'S 1013-1016 (September 9, 1980)
  • K800947 — MIDSTREAM COLLECTION KIT (May 30, 1980)
  • K800309 — SPECIMEN COLLECTION PAN (February 26, 1980)
  • K800233 — ABCO MIDSTREAM URINE COLLECTION SET (February 26, 1980)
  • K792710 — PARA-PAK CLEAN VIAL (January 28, 1980)

FDA data resources