The following data is part of a premarket notification filed by Integrated Orbital Implants, Inc. with the FDA for Perry-kolberg (pk) Titanium Motility/support System.
| Device ID | K974203 |
| 510k Number | K974203 |
| Device Name: | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM |
| Classification | Ocular Peg |
| Applicant | INTEGRATED ORBITAL IMPLANTS, INC. 4329 GRAYDON RD. San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson INTEGRATED ORBITAL IMPLANTS, INC. 4329 GRAYDON RD. San Diego, CA 92130 |
| Product Code | MQU |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-10 |
| Decision Date | 1998-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854066006212 | K974203 | 000 |
| 00854066006205 | K974203 | 000 |
| 00854066006199 | K974203 | 000 |
| 00854066006182 | K974203 | 000 |
| 00854066006175 | K974203 | 000 |
| 00854066006168 | K974203 | 000 |