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510(k) K940152

CAMERA COVER WITH TEAR TIP by Hydro-Med Products, Inc. — Product Code FEM

K940152 is an FDA 510(k) premarket notification submitted by Hydro-Med Products, Inc. for the device "CAMERA COVER WITH TEAR TIP". The FDA issued a decision of Substantially Equivalent on October 28, 1994. The device falls under product code FEM (Accessories, Photographic, For Endoscope (Exclude Light Sources)), a Class I device regulated under 21 CFR 876.1500. Hydro-Med Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1994
Date Received
January 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Photographic, For Endoscope (Exclude Light Sources)
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Hydro-Med Products, Inc.

  • K944198 — SURGICAL MICROSCOPE DRAPE (November 27, 1994)
  • K940151 — ULTRASOUND PROBE DRAPE (November 14, 1994)
  • K934630 — UNIVERSAL VIDEO/LASER ARM DRAPE (October 28, 1994)
  • K923099 — X-RAY DRAPES (October 15, 1992)
  • K863872 — TAMPER HAMPER (February 10, 1987)
  • K853281 — EASYTOP (August 21, 1985)
  • K842304 — THE PATHFINDER (August 1, 1984)
  • K834407 — STERILE DISPOSABLE SPINAL NEEDLES (March 19, 1984)
  • K812405 — STERILE TV CAMERA & CORD COVER (October 20, 1981)
  • K790659 — INFANT SCALE DISPOSABLE LINER (April 30, 1979)

Other clearances for product code FEM

  • K812201 — PHOTOGRAPHIC EQUIPMENT (October 19, 1981)
  • K812542 — POLAROID INSTANT ENDOCAMERA (October 19, 1981)
  • K792512 — POLAROID LAND CAMERA FOR ENDOSCOPY (December 20, 1979)

FDA data resources