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510(k) K940133

THE EXPANDACELL EAR PACK by Denver Splint Co. — Product Code LRD

K940133 is an FDA 510(k) premarket notification submitted by Denver Splint Co. for the device "THE EXPANDACELL EAR PACK". The FDA issued a decision of Substantially Equivalent on May 23, 1994. The device falls under product code LRD (Applicator, Ent Drug), a Class I device regulated under 21 CFR 874.5220. Denver Splint Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1994
Date Received
January 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Ent Drug
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

Other clearances by Denver Splint Co.

  • K940798 — SHIPPERT PRESSURE BANDAGE (September 28, 1994)
  • K935724 — THE EXPANDACELL SINUS PACK (May 12, 1994)
  • K922062 — THE DENVER CAUTERY (January 12, 1993)

Other clearances for product code LRD

  • K984345 — AROMAPATCH (March 19, 1999)
  • K932522 — AMSCO STERILE RECOVERIES SURGICAL PACKS (September 9, 1994)
  • K942789 — MISTASSIST (August 12, 1994)
  • K925022 — SURGICAL TRAY (STERILE) (April 26, 1993)
  • K920842 — AEROSOL DELIVERY SYSTEMS (May 15, 1992)

FDA data resources