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510(k) K882613

ALM SURGICAL LAMPS by Alm Surgical Equipment, Inc. — Product Code FTD

K882613 is an FDA 510(k) premarket notification submitted by Alm Surgical Equipment, Inc. for the device "ALM SURGICAL LAMPS". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Alm Surgical Equipment, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
June 24, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Alm Surgical Equipment, Inc.

  • K982063 — ALM PRISMALIX (PRX) SURGICAL LIGHT (September 22, 1998)
  • K961886 — DRAGER GEMINA WALL-MOUNTED WORKPLACE (July 30, 1996)
  • K961742 — DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (July 26, 1996)
  • K945102 — MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE (November 4, 1994)
  • K942043 — DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E (July 13, 1994)
  • K922409 — ALM ILLUMINATOR SERIES LIGHT SYSTEM (January 12, 1993)
  • K921297 — DRAGER DVE 4000 SERIES SYSTEM (November 27, 1992)
  • K921848 — BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT (October 1, 1992)
  • K884019 — ALM OPERATING TABLES (October 13, 1988)

Other clearances for product code FTD

  • K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL (December 5, 2013)
  • K130513 — VOLISTA 400; VOLISTA 600 (May 8, 2013)
  • K123776 — POLARIS 100/200 (March 8, 2013)
  • K111020 — ATRICURE DISSECTOR (June 9, 2011)
  • K100234 — HM-LAMP II (July 8, 2010)
  • K100884 — STRYKER KNIFELIGHT (June 25, 2010)
  • K071180 — SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (June 20, 2007)
  • K053364 — HALUX IRIS EXAMINATION AND SURGICAL LAMP (February 23, 2006)
  • K041681 — ATRICURE DISSECTOR (July 1, 2004)
  • K013242 — AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (December 13, 2001)

FDA data resources