The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad H/s Procedure Tray.
| Device ID | K881680 |
| 510k Number | K881680 |
| Device Name: | ACKRAD H/S PROCEDURE TRAY |
| Classification | Insufflator, Hysteroscopic |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman,phd |
| Correspondent | Bernard Ackerman,phd ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-19 |
| Decision Date | 1988-07-15 |