The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Circumcision Tray, Cat. No. 70340.
| Device ID | K974286 |
| 510k Number | K974286 |
| Device Name: | CIRCUMCISION TRAY, CAT. NO. 70340 |
| Classification | Clamp, Circumcision |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-14 |
| Decision Date | 1997-12-12 |