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510(k) K761093

BANDAGE by Paco Pharmaceutical Services, Inc. — Product Code NAD

K761093 is an FDA 510(k) premarket notification submitted by Paco Pharmaceutical Services, Inc. for the device "BANDAGE". The FDA issued a decision of Substantially Equivalent on January 6, 1977. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Paco Pharmaceutical Services, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1977
Date Received
November 22, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Paco Pharmaceutical Services, Inc.

  • K865111 — CHARTER HARD CONTACT LENS CLEANING SOLUTION (January 20, 1987)
  • K863974 — CHARTER LABORATORIES INC. LENS LUBRICANT (November 10, 1986)
  • K862952 — CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES (September 25, 1986)
  • K843797 — STERILE SALINE SOLUTION (January 18, 1985)
  • K843796 — STERILE WATER (December 10, 1984)

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)

FDA data resources