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510(k) K932522

AMSCO STERILE RECOVERIES SURGICAL PACKS by Amsco Sterile Recoveries, Inc. — Product Code LRD

K932522 is an FDA 510(k) premarket notification submitted by Amsco Sterile Recoveries, Inc. for the device "AMSCO STERILE RECOVERIES SURGICAL PACKS". The FDA issued a decision of Substantially Equivalent on September 9, 1994. The device falls under product code LRD (Applicator, Ent Drug), a Class I device regulated under 21 CFR 874.5220. Amsco Sterile Recoveries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1994
Date Received
May 25, 1993
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 Amsco Sterile Recoveries, Inc.

  • K931143 — AMSCO STERILE RECOVERIES ABSORBENT TOWELS (September 8, 1994)
  • K931146 — SURGICAL DRAPES, MODIFICATION (June 13, 1994)
  • K931874 — RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE (June 10, 1994)
  • K931875 — AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE (June 10, 1994)
  • K931144 — STERILE SURGEON'S GOWN, MODIFICATION (June 10, 1994)
  • K931145 — NON-STERILE ISOLATION GOWN (June 10, 1994)
  • K932035 — NON-LINTING DELIVERY BLANKET (May 26, 1994)
  • K925815 — REUSABLE LIQUIDPROOF BOOTIE (July 9, 1993)
  • K921049 — SURGICAL DRAPE (October 1, 1992)
  • K920404 — SURGEON'S GOWN (August 18, 1992)

Other clearances for product code LRD

  • K984345 — AROMAPATCH (March 19, 1999)
  • K942789 — MISTASSIST (August 12, 1994)
  • K940133 — THE EXPANDACELL EAR PACK (May 23, 1994)
  • K925022 — SURGICAL TRAY (STERILE) (April 26, 1993)
  • K920842 — AEROSOL DELIVERY SYSTEMS (May 15, 1992)

FDA data resources