Home / 510(k) Clearances / K945727

510(k) K945727

CATCO NEONATAL PALATE GUARD by Catco Medical, Inc. — Product Code BRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1994
Date Received
November 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Dental
Device Class
Class I
Regulation Number
868.5820
Review Panel
AN
Submission Type

Other clearances by Catco Medical, Inc.

  • K945728 — CATCO THORACIC CATHETER (May 23, 1995)
  • K944368 — CATCO SILICONE UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944410 — CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944336 — CATCO UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944367 — CATCO POLYURETHANE UMBILICAL VESSEL CATHETER (April 5, 1995)
  • K944504 — CATCO FIRST PICC (March 31, 1995)
  • K944685 — CATO FIRST PICC-DUAL LUMEN (March 31, 1995)
  • K945012 — CATCO NUTRITIONAL CATHETER (February 24, 1995)
  • K945258 — CATCO URINARY COLLECTION KIT (February 16, 1995)
  • K945499 — CATO FIRST PICC KIT (February 7, 1995)

Other clearances for product code BRW

  • K935713 — WILEY/ESPOSITO DENTAL GUARD (January 5, 1994)
  • K851640 — TIP TOLEDO INCISOR PROTECTOR (September 18, 1985)