The following data is part of a premarket notification filed by Iob Medical Inc with the FDA for Iob Disposable Speculum.
Device ID | K132668 |
510k Number | K132668 |
Device Name: | IOB DISPOSABLE SPECULUM |
Classification | Speculum, Vaginal, Nonmetal |
Applicant | IOB MEDICAL INC 504E DIAMOND AVE. SUITE F Gaithersburg, MD 20877 |
Contact | Joe Xia |
Correspondent | Joe Xia IOB MEDICAL INC 504E DIAMOND AVE. SUITE F Gaithersburg, MD 20877 |
Product Code | HIB |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-27 |
Decision Date | 2014-01-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06951013000416 | K132668 | 000 |
06951013000409 | K132668 | 000 |
06951013000393 | K132668 | 000 |