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510(k) K822481

MULTIPLE SURGICAL MASK by Surgilite Intl., Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1982
Date Received
August 17, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Surgilite Intl., Inc.

  • K823671 — NO-GAUZE LAPAROTOMY SPONGE (January 9, 1983)
  • K822482 — SURGILITE NON-WOVEN WRAP (September 21, 1982)
  • K822483 — MULTIPLE SCRUB SUIT (September 17, 1982)
  • K771531 — LAPAROTOMY SPONGES (September 6, 1977)

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