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510(k) K911132

MULTIPLE, SURGICAL DRAPE PACK by Central Georgia Ancillary Health Systems — Product Code FZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1991
Date Received
March 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Air Handling, Enclosure
Device Class
Class II
Regulation Number
878.5070
Review Panel
SU
Submission Type

Other clearances by Central Georgia Ancillary Health Systems

  • K923798 — SURGICAL GOWN PACK (January 27, 1993)
  • K911131 — STERILE SURGICAL GOWN PACK (September 16, 1991)

Other clearances for product code FZI

  • K910468 — STERILE DISPOSABLE DRAPE(S) (March 21, 1991)
  • K854159 — ELLIPTI-PUNCH (November 15, 1985)
  • K772395 — DAVIS RHYTIDECTOMY (March 9, 1978)
  • K772394 — KALRN FACE-LIFE SCISSORS (March 9, 1978)