The following data is part of a premarket notification filed by T.s. Medical with the FDA for T.s. Medical Circumcision Clamp.
Device ID | K033403 |
510k Number | K033403 |
Device Name: | T.S. MEDICAL CIRCUMCISION CLAMP |
Classification | Clamp, Circumcision |
Applicant | T.S. MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Contact | Carolann Kotula |
Correspondent | Carolann Kotula T.S. MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Product Code | HFX |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-24 |
Decision Date | 2004-01-22 |
Summary: | summary |