The following data is part of a premarket notification filed by Solos Endoscopy, Inc. with the FDA for Miniaturized Biopsy,scope A.k.a: Biopsy Needle With Endoscopic Viewing Capability.
| Device ID | K983538 |
| 510k Number | K983538 |
| Device Name: | MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SOLOS ENDOSCOPY, INC. 41 BROOKS DR. Braintree, MA 02184 |
| Contact | Paul Dias |
| Correspondent | Paul Dias SOLOS ENDOSCOPY, INC. 41 BROOKS DR. Braintree, MA 02184 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-09 |
| Decision Date | 1998-11-06 |
| Summary: | summary |