The following data is part of a premarket notification filed by Amsino Intl., Inc. with the FDA for Amsino Disposable Viginal Speculum.
Device ID | K951528 |
510k Number | K951528 |
Device Name: | AMSINO DISPOSABLE VIGINAL SPECULUM |
Classification | Speculum, Vaginal, Nonmetal |
Applicant | AMSINO INTL., INC. 222 SOUTH FIFTH AVE. City Of Industry, CA 91746 -2900 |
Contact | Richard Y Li |
Correspondent | Richard Y Li AMSINO INTL., INC. 222 SOUTH FIFTH AVE. City Of Industry, CA 91746 -2900 |
Product Code | HIB |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-03 |
Decision Date | 1995-05-11 |