The following data is part of a premarket notification filed by Ormed Mfg., Inc. with the FDA for Strung Neuro Sponge Patties, X-ray Opague.
| Device ID | K852202 |
| 510k Number | K852202 |
| Device Name: | STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE |
| Classification | Gauze/sponge, Internal |
| Applicant | ORMED MFG., INC. 175 GREAT ARROW AVE. Buffalo, NY 14207 |
| Contact | David H Power |
| Correspondent | David H Power ORMED MFG., INC. 175 GREAT ARROW AVE. Buffalo, NY 14207 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-21 |
| Decision Date | 1985-06-26 |