The following data is part of a premarket notification filed by Rb Health (us) Llc with the FDA for Durex Penck Iii Regular.
Device ID | K222068 |
510k Number | K222068 |
Device Name: | Durex Penck III Regular |
Classification | Condom |
Applicant | RB Health (US) LLC 399 Interpace Parkway Parsippany, NJ 07054 |
Contact | Kyle Prince |
Correspondent | Kyle Prince RB Health (US) LLC 399 Interpace Parkway Parsippany, NJ 07054 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-07-14 |
Decision Date | 2022-10-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
99067981087981 | K222068 | 000 |
50302340876587 | K222068 | 000 |
50302340876570 | K222068 | 000 |
10067981087984 | K222068 | 000 |
10067981087977 | K222068 | 000 |