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510(k) K960241

CPR GENERAL SURGERY TRAY by Custom Pack Reliability — Product Code LWI

K960241 is an FDA 510(k) premarket notification submitted by Custom Pack Reliability for the device "CPR GENERAL SURGERY TRAY". The FDA issued a decision of Substantially Equivalent on March 22, 1996. The device falls under product code LWI (Ultrasound, Sinus), a Class II device regulated under 21 CFR 892.1560. Custom Pack Reliability has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1996
Date Received
January 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasound, Sinus
Device Class
Class II
Regulation Number
892.1560
Review Panel
EN
Submission Type

Other clearances by Custom Pack Reliability

  • K960205 — CPR TRACHEOTOMY CARE TRAY (August 27, 1996)
  • K960243 — CPR C-SECTION DELIVERY PACK (May 23, 1996)
  • K960239 — CPR D & C TRAY (May 23, 1996)
  • K960216 — CPR SUCTION CATHETER KIT (April 15, 1996)
  • K960210 — CPR ORTHO HAND PACK (April 12, 1996)
  • K960206 — CPR DRESSING CHANGE TRAY (April 12, 1996)
  • K960211 — CPR TOTAL KNEE PACK (April 12, 1996)
  • K960213 — CPR TOTAL HIP PACK (April 12, 1996)
  • K960209 — CPR HEART PACK (April 4, 1996)
  • K960212 — CPR IRRIGATION TRAY (April 1, 1996)

Other clearances for product code LWI

  • K960421 — SINUSCAN 102/SINUSPRINT (April 16, 1997)
  • K960044 — ULTRAMAX/MODEL NUMBER A1 (August 2, 1996)
  • K874081 — ENTERSCAN (December 31, 1987)

FDA data resources