FDA 510(k) Applications for Medical Device Product Code: FAM (Sigmoidoscope And Accessories, Flexible/Rigid)

FDA 510(k) Applications for Medical Device Product Code "FAM"
(Sigmoidoscope And Accessories, Flexible/Rigid)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K964131	AKOS BIOMEDICAL, INC.	ENDOSCOPE	06/27/1997
K951577	PENTAX PRECISION INSTRUMENT CORP.	ES-3800, VIDEO SIGMOIDOSCOPE	03/21/1996
K961567	PENTAX PRECISION INSTRUMENT CORP.	ES-3840, VIDEO SIGMOIDOSCOPE	06/24/1996
K963344	VISION-SCIENCES, INC.	DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE	11/21/1996
K964326	VISION-SCIENCES, INC.	VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM	01/03/1997
K964100	VISION-SCIENCES, INC.	VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100	12/16/1996
K970382	WELCH ALLYN, INC.	VS-100 VIDEO SIGMOIDOSCOPE	04/17/1997