The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Infa-length.
Device ID | K932112 |
510k Number | K932112 |
Device Name: | OLYMPIC INFA-LENGTH |
Classification | Tape, Measuring, Rulers And Calipers |
Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
Contact | Joseph Stefanile |
Correspondent | Joseph Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
Product Code | FTY |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-03 |
Decision Date | 1993-07-22 |