The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Grice Laparoscopic Suturing Needle.
| Device ID | K921922 |
| 510k Number | K921922 |
| Device Name: | GRICE LAPAROSCOPIC SUTURING NEEDLE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-23 |
| Decision Date | 1992-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663102020 | K921922 | 000 |