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510(k) K780394

GAUZE FLUFF by The Torrent Corp. — Product Code NAB

K780394 is an FDA 510(k) premarket notification submitted by The Torrent Corp. for the device "GAUZE FLUFF". The FDA issued a decision of Substantially Equivalent on Apr 10, 1978. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. The Torrent Corp. has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 10, 1978
Date Received
Mar 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze / Sponge,Nonresorbable For External Use
Device Class
Class I
Regulation Number
878.4014
Review Panel
SU
Submission Type
510(k) Exempt

Other clearances by The Torrent Corp.

  • K842461 — TONGUE DEPRESSOR (Nov 30, 1984)
  • K770621 — STOCKINETTE, SURGICAL (Apr 6, 1977)

Other clearances for product code NAB

  • K946015 — IVALON EXTERNAL SPONGE (Feb 27, 1995)
  • K940755 — ISOLYER (4X4, 8PLY) (May 2, 1994)
  • K931610 — OMNISORB II, NONWOVEN SPONGE, STERILE AND NON (Jun 24, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (Apr 8, 1993)
  • K926072 — K-BAND AND K-CREPE (Mar 19, 1993)
  • K915591 — STERILE GAUZE PADS (Jan 27, 1993)
  • K924650 — GAUZE SPONGES (Jan 11, 1993)
  • K923602 — ABSORBENT PAD -- MODIFICATION (Dec 7, 1992)
  • K923115 — CLINISORB (Nov 23, 1992)
  • K923378 — USP TYPE VII GAUZE SPONGES (Oct 6, 1992)

FDA data resources

Source: FDA 510(k) database entry for K780394. Report a data issue: hello@regdatalab.com.