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510(k) K840492

SUN-LITE BLUE SLIT by Suncoast Medical Manufacturers, Inc. — Product Code HTP

K840492 is an FDA 510(k) premarket notification submitted by Suncoast Medical Manufacturers, Inc. for the device "SUN-LITE BLUE SLIT". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code HTP (File), a Class I device regulated under 21 CFR 888.4540. Suncoast Medical Manufacturers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
February 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Suncoast Medical Manufacturers, Inc.

  • K841509 — REPLACE-A-TIP ADJUSTABLE HIGH TEMP. (December 7, 1984)
  • K841459 — REPLACE-A-TIP ADJUST. LOW TEMP.- (December 7, 1984)
  • K841603 — ADJUST-A-TEMP MICRO (December 7, 1984)
  • K841604 — ADJUST-A-TEMP HIGH TEMPERATURE (December 7, 1984)
  • K841591 — PYRO-TIP (October 31, 1984)
  • K840376 — SURG-A STAT LOOP TIP (October 26, 1984)
  • K840375 — SURG-A-STAT LOOP TIP 15 (July 23, 1984)
  • K840370 — SURG-A-STAT VASECTOMY TIP (July 23, 1984)
  • K840377 — SURG-A-STAT CARDIOVASCULAR TIP (July 23, 1984)
  • K840387 — SURG-A-STAT LOOP TIP 2 (July 23, 1984)

Other clearances for product code HTP

  • K931733 — INTERMEDICS ORTHOPEDICS REAMERS (January 26, 1994)
  • K870842 — SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (May 27, 1987)
  • K862659 — CONCEPT ARTHROSCOPY RASP (September 2, 1986)
  • K841981 — 4MM & 5MM FILE (June 19, 1984)

FDA data resources