The following data is part of a premarket notification filed by Laboratoires Perouse with the FDA for Polyperf / Polyperf Safe.
Device ID | K063631 |
510k Number | K063631 |
Device Name: | POLYPERF / POLYPERF SAFE |
Classification | Set, Administration, Intravascular |
Applicant | LABORATOIRES PEROUSE Route Du Manoir Ivry Le Temple, FR 60173 |
Contact | Marie Noelle Erout |
Correspondent | Marie Noelle Erout LABORATOIRES PEROUSE Route Du Manoir Ivry Le Temple, FR 60173 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-06 |
Decision Date | 2007-10-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
13661234014269 | K063631 | 000 |
13661234014078 | K063631 | 000 |
13661234014061 | K063631 | 000 |
13661234014054 | K063631 | 000 |
13661234014047 | K063631 | 000 |
13661234014030 | K063631 | 000 |
13661234014023 | K063631 | 000 |
13661234014016 | K063631 | 000 |
13661234014009 | K063631 | 000 |
13661234013996 | K063631 | 000 |
13661234013989 | K063631 | 000 |
13661234013972 | K063631 | 000 |
13661234013965 | K063631 | 000 |
13661234013958 | K063631 | 000 |
13661234013941 | K063631 | 000 |
13661234013934 | K063631 | 000 |
13661234013927 | K063631 | 000 |
13661234014085 | K063631 | 000 |
13661234014092 | K063631 | 000 |
13661234014252 | K063631 | 000 |
13661234014245 | K063631 | 000 |
13661234014238 | K063631 | 000 |
13661234014221 | K063631 | 000 |
13661234014214 | K063631 | 000 |
13661234014207 | K063631 | 000 |
13661234014191 | K063631 | 000 |
13661234014184 | K063631 | 000 |
13661234014177 | K063631 | 000 |
13661234014160 | K063631 | 000 |
13661234014153 | K063631 | 000 |
13661234014146 | K063631 | 000 |
13661234014139 | K063631 | 000 |
13661234014122 | K063631 | 000 |
13661234014115 | K063631 | 000 |
13661234014108 | K063631 | 000 |
13661234013910 | K063631 | 000 |