The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Pds Plates.
| Device ID | K092590 |
| 510k Number | K092590 |
| Device Name: | PDS PLATES |
| Classification | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Applicant | ETHICON, INC. U.S. ROUTE 22, WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Leslie Young |
| Correspondent | Leslie Young ETHICON, INC. U.S. ROUTE 22, WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | NHB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-24 |
| Decision Date | 2010-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031087986 | K092590 | 000 |
| 20705031087948 | K092590 | 000 |
| 20705031087955 | K092590 | 000 |
| 10705031087965 | K092590 | 000 |
| 20705031087979 | K092590 | 000 |
| 10705031087989 | K092590 | 000 |
| 20705031087993 | K092590 | 000 |
| 20705031088006 | K092590 | 000 |
| 20705031132518 | K092590 | 000 |
| 20705031132525 | K092590 | 000 |
| 20705031132532 | K092590 | 000 |
| 20705031087962 | K092590 | 000 |
| 20705031087931 | K092590 | 000 |