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510(k) K882695

RUBBER BAND, STERILE by Bioseal — Product Code ECI

K882695 is an FDA 510(k) premarket notification submitted by Bioseal for the device "RUBBER BAND, STERILE". The FDA issued a decision of Substantially Equivalent on October 13, 1988. The device falls under product code ECI (Band, Elastic, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Bioseal has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1988
Date Received
June 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Band, Elastic, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances by Bioseal

  • K893814 — SURGICAL INSTRUMENT KIT, DISPOSABLE (August 10, 1989)
  • K882696 — DERMICEL, MONTGOMERY STRAP (August 26, 1988)
  • K882694 — FIXATION DEVICE, TRACH TUBE (August 15, 1988)
  • K882709 — TONSIL SPONGE, X-RAY DETECTABLE, W/STRING (August 3, 1988)
  • K882710 — INTESTINAL SPONGES (August 3, 1988)
  • K882712 — STICK SPONGE (August 3, 1988)
  • K882707 — GAUZE PACKING, X-RAY DETECTABLE (August 3, 1988)
  • K882711 — GAUZE SPONGE 12PLY (August 3, 1988)
  • K882708 — GAUZE SPONGE, X-RAY DETECTABLE (August 3, 1988)

Other clearances for product code ECI

  • K980864 — POWER COINS GLOW IN THE DARK LIGATURES (April 20, 1998)
  • K980053 — GLENROE CHAIN (February 24, 1998)
  • K973495 — GLENROE GLOW IN DARK ELASTOMERIC LIGATURES (December 1, 1997)
  • K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE (May 24, 1995)
  • K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD (May 23, 1995)
  • K943420 — ORTHODONTIC ELASTOMERIC CHAIN (May 23, 1995)
  • K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (May 23, 1995)
  • K940165 — ALASTIK (March 7, 1994)
  • K932298 — PRO'S NEO-LASTICS (February 14, 1994)
  • K935144 — DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS (February 4, 1994)

FDA data resources