The following data is part of a premarket notification filed by Global Protection Corp. with the FDA for Male Latex Condom.
Device ID | K203536 |
510k Number | K203536 |
Device Name: | Male Latex Condom |
Classification | Condom |
Applicant | Global Protection Corp. 12 Channel Street Boston, MA 02210 |
Contact | Christina Cataldo |
Correspondent | Christina Cataldo Global Protection Corp. 12 Channel Street Boston, MA 02210 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-12-03 |
Decision Date | 2021-09-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
80726893115138 | K203536 | 000 |
10726893115139 | K203536 | 000 |
80726893115121 | K203536 | 000 |
20726893116898 | K203536 | 000 |
20726893118113 | K203536 | 000 |
80726893118337 | K203536 | 000 |