The following data is part of a premarket notification filed by Sparco, Inc. with the FDA for Sparco Scope Guard.
| Device ID | K850268 |
| 510k Number | K850268 |
| Device Name: | SPARCO SCOPE GUARD |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | SPARCO, INC. P.O. BOX 20369 Castro Valley, CA 94546 |
| Contact | Beverly J Sparks |
| Correspondent | Beverly J Sparks SPARCO, INC. P.O. BOX 20369 Castro Valley, CA 94546 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-23 |
| Decision Date | 1985-04-15 |