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510(k) K950560

SALINE SOLUTINE, STERILE by Busse Hospital Disposables, Inc. — Product Code IGE

K950560 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "SALINE SOLUTINE, STERILE". The FDA issued a decision of Substantially Equivalent on May 30, 1995. The device falls under product code IGE (Solution, Formalin Ammonium Bromide), a Class I device regulated under 21 CFR 864.4010. Busse Hospital Disposables, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1995
Date Received
February 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Formalin Ammonium Bromide
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Busse Hospital Disposables, Inc.

  • K141285 — BUSSE EXTENSION SET (February 19, 2015)
  • K120002 — I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE (June 26, 2012)
  • K110883 — J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION (June 8, 2011)
  • K093920 — BUSSE EPIDURAL CATHETER KIT (August 6, 2010)
  • K093909 — BUSSE SURGICAL DRAPES IV (May 6, 2010)
  • K092212 — BUSSE SURGICAL DRAPES III (October 9, 2009)
  • K082297 — BUSSE SURGICAL DRAPE (December 9, 2008)
  • K073222 — MODIFICATION TO:SPECIALTY NEEDLES (April 9, 2008)
  • K070465 — BUSSE EPIDURAL CATHETER (July 19, 2007)
  • K063018 — GLASS LOSS OF RESISTANCE SYRINGE (January 22, 2007)

Other clearances for product code IGE

  • K842862 — CB FORMALIN (August 28, 1984)

FDA data resources