The following data is part of a premarket notification filed by International Hospital Supply Co. with the FDA for Blades For Spinal Laminectomy Retractor.
| Device ID | K910621 |
| 510k Number | K910621 |
| Device Name: | BLADES FOR SPINAL LAMINECTOMY RETRACTOR |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | INTERNATIONAL HOSPITAL SUPPLY CO. 18321 VENTURA BLVD. #1010 Tarzana, CA 91356 |
| Contact | George O Shecter |
| Correspondent | George O Shecter INTERNATIONAL HOSPITAL SUPPLY CO. 18321 VENTURA BLVD. #1010 Tarzana, CA 91356 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-04-01 |