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 |