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510(k) K820443

SURGI-SCRAPE by Consolidated Medical Equipment, Inc.

K820443 is an FDA 510(k) premarket notification submitted by Consolidated Medical Equipment, Inc. for the device "SURGI-SCRAPE". The FDA issued a decision of Substantially Equivalent on March 8, 1982. Consolidated Medical Equipment, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1982
Date Received
February 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Consolidated Medical Equipment, Inc.

  • K854040 — I.V. DRESSING (January 9, 1986)
  • K850130 — PRN ECG ELECTRODE (April 9, 1985)
  • K850132 — DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC (April 9, 1985)
  • K850037 — CLOSED WOUND DRAIN (March 19, 1985)
  • K844942 — PLURA-GARD CHEST DRAINAGE SYSTEM (March 12, 1985)
  • K850311 — DISPOS. CONDUCTIVE ADHESIVE TENS PAD (March 5, 1985)
  • K850131 — CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS (March 5, 1985)
  • K850133 — VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. (February 28, 1985)
  • K850129 — MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN (February 28, 1985)
  • K844372 — HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE (February 21, 1985)

FDA data resources