The following data is part of a premarket notification filed by Precise Optics with the FDA for Endoscopes.
| Device ID | K914084 |
| 510k Number | K914084 |
| Device Name: | ENDOSCOPES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PRECISE OPTICS 22 EAST BROADWAY Gardner, MA 01440 |
| Contact | Francis L Pugsley |
| Correspondent | Francis L Pugsley PRECISE OPTICS 22 EAST BROADWAY Gardner, MA 01440 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-04 |
| Decision Date | 1992-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856164008174 | K914084 | 000 |
| 00856164008167 | K914084 | 000 |
| 00856164008150 | K914084 | 000 |
| 00856164008143 | K914084 | 000 |
| 00856164008082 | K914084 | 000 |
| 00856164008020 | K914084 | 000 |
| 00856164008013 | K914084 | 000 |
| 00856164008006 | K914084 | 000 |