The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for Mayfield* A-2000 Skull Clamp.
| Device ID | K932807 |
| 510k Number | K932807 |
| Device Name: | MAYFIELD* A-2000 SKULL CLAMP |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227 |
| Contact | Dennis R Lackey |
| Correspondent | Dennis R Lackey OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-09 |
| Decision Date | 1993-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268GS7571 | K932807 | 000 |
| M268422A10121 | K932807 | 000 |
| M268422A10101 | K932807 | 000 |
| M268422A10091 | K932807 | 000 |
| M268422A10071 | K932807 | 000 |
| M268422A10061 | K932807 | 000 |
| M268422A10051 | K932807 | 000 |
| M268422A10041 | K932807 | 000 |
| M268422A10031 | K932807 | 000 |
| M268422A10021 | K932807 | 000 |
| M26841A14181 | K932807 | 000 |
| M268A2000SRL1 | K932807 | 000 |
| M268A1064P1 | K932807 | 000 |
| M268422A10141 | K932807 | 000 |
| M268422A10161 | K932807 | 000 |
| M268422A10171 | K932807 | 000 |
| M268GS5681 | K932807 | 000 |
| M268GS5671 | K932807 | 000 |
| M268GS3571 | K932807 | 000 |
| M268431A10311 | K932807 | 000 |
| M268422C10021 | K932807 | 000 |
| M268422C10011 | K932807 | 000 |
| M268422C10001 | K932807 | 000 |
| M268422B10111 | K932807 | 000 |
| M268422A10231 | K932807 | 000 |
| M268422A10221 | K932807 | 000 |
| M268422A10201 | K932807 | 000 |
| M268422A10181 | K932807 | 000 |
| M268A20001 | K932807 | 000 |