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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 Mar 8, 1982. Consolidated Medical Equipment, Inc. has 14 other 510(k) clearances on record.

Clearance details

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

Other clearances by Consolidated Medical Equipment, Inc.

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

FDA data resources

Source: FDA 510(k) database entry for K820443. Report a data issue: hello@regdatalab.com.