The following data is part of a premarket notification filed by Ormed Mfg., Inc. with the FDA for Modified Round (beehive) Dissector 3/8.
| Device ID | K873391 |
| 510k Number | K873391 |
| Device Name: | MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8 |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | ORMED MFG., INC. 175 GREAT ARROW AVE. Buffalo, NY 14207 |
| Contact | Alex Balaz |
| Correspondent | Alex Balaz ORMED MFG., INC. 175 GREAT ARROW AVE. Buffalo, NY 14207 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-24 |
| Decision Date | 1987-09-11 |