The following data is part of a premarket notification filed by A.w. Showell (surgicraft) Ltd. with the FDA for Surgicraft Copeland Disposable.
| Device ID | K844608 |
| 510k Number | K844608 |
| Device Name: | SURGICRAFT COPELAND DISPOSABLE |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | A.W. SHOWELL (SURGICRAFT) LTD. BRITTEN ST. REDDITCH Worcs. B97 6hf England, GB |
| Contact | Showell |
| Correspondent | Showell A.W. SHOWELL (SURGICRAFT) LTD. BRITTEN ST. REDDITCH Worcs. B97 6hf England, GB |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-27 |
| Decision Date | 1985-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270977168 | K844608 | 000 |
| 05055270977137 | K844608 | 000 |