The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Kleenspec.
Device ID | K941272 |
510k Number | K941272 |
Device Name: | KLEENSPEC |
Classification | Speculum, Vaginal, Nonmetal |
Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
Contact | Lawrence E Morocco |
Correspondent | Lawrence E Morocco WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
Product Code | HIB |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-16 |
Decision Date | 1994-08-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KLEENSPEC 77966840 3879145 Live/Registered |
Welch Allyn, Inc. 2010-03-24 |
KLEENSPEC 73715851 1554549 Dead/Cancelled |
WELCH ALLYN, INC. 1988-03-10 |
KLEENSPEC 73050561 1035716 Dead/Expired |
WELCH ALLYN, INC. 1975-04-25 |
KLEENSPEC 72016642 0647923 Live/Registered |
WELCH ALLYN, INC. 1956-09-28 |